U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Iplan rt radiation treatment planning software: potentially incorrect patient positioning when using multiple localized ct image data sets.
Acción
Brainlab sent a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated November 19, 2014, to all affected customers. The letter included instructions to:
1) If clinically not required, do not use multiple localized CT scans within one treatment plan (to avoid potentially incorrect Reference and Alignment Set assignments in the first place).
2) If you must use multiple localized CT scans, e.g. for recurrent treatment planning of the same patient, always guarantee that the latest (see note *) CT scan is defined as both Alignment Set and Reference Set during treatment planning. Brainlab will provide a software solution to prevent the described scenario from occurring.
Brainlab will actively contact affected customers tentatively starting January 2016 to schedule the update. Brainlab will additionally refine the instructions for use of the iPlan RT treatment planning software in regard to implications of Alignment Set and Reference Set selections and will provide this user guide update to existing affected customers together with the software update.
Customers with questions can contact Brainlab at 800-597-5911 or via e-mail at us.support@brainlab.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Iplan rt radiation treatment planning software: potentially incorrect patient positioning when using multiple localized ct image data sets.
Acción
Brainlab sent a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated November 19, 2014, to all affected customers. The letter included instructions to:
1) If clinically not required, do not use multiple localized CT scans within one treatment plan (to avoid potentially incorrect Reference and Alignment Set assignments in the first place).
2) If you must use multiple localized CT scans, e.g. for recurrent treatment planning of the same patient, always guarantee that the latest (see note *) CT scan is defined as both Alignment Set and Reference Set during treatment planning. Brainlab will provide a software solution to prevent the described scenario from occurring.
Brainlab will actively contact affected customers tentatively starting January 2016 to schedule the update. Brainlab will additionally refine the instructions for use of the iPlan RT treatment planning software in regard to implications of Alignment Set and Reference Set selections and will provide this user guide update to existing affected customers together with the software update.
Customers with questions can contact Brainlab at 800-597-5911 or via e-mail at us.support@brainlab.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Stent, carotid - Product Code NIM
Causa
Two production lots of the protege rx tapered carotid stent systems (secx-10-7-40-135, lot # 9922452 & sepx-8-6-40-135, lot # 9922795) because of a product labeling error.
Acción
Consignees were sent on 12/4/2014 a Covidien "Urgent Field Safety Notice" letter dated 4th December 2014. The letter described the problem and the product involved in the recall. Advised consignees to quarantine, discontinue use of the device and return the product to Covidien. They also requested consignees to complete the "Recall Verification Form" and return it to Covidien. For questions, customers can contact their local Covidien Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Test, time, prothrombin - Product Code GJS
Causa
In certain cases, an inratio pt/inr monitor system may provide an inr result that is significantly lower than a result obtained using a reference inr system (laboratory method). this issue can arise if the patient has certain medical conditions. it can also occur if the instructions in the labeling for performing the test are not followed.
Acción
An Urgent: Medical Device Correction, dated December 5, 2014, was sent to Healthcare Professionals. The letter identified the affected product and reason for recall. Customers were instructed to:
-Ensure they have read and understand the precautions described in the current product labeling (a complete list of product labeling is provided in Appendix A) and the additional precautions in this notice describing medical conditions that may increase the risk of obtaining a (falsely or erroneously) lower than expected INR result. The INRatio PT/INR Monitor system should NOT be used if the patient has any of the medical conditions described.
-Verify that the patient has hematocrit within the range of 30% to 55%. If not, immediately transition the patient to an alternate INR monitoring method.
-Perform INR verification testing for the patients using a laboratory INR test method. Immediately transition any patient with a significantly discrepant low result on the INRatio¿¿ PT/INR Monitor system to an alternative INR monitoring method.
-If have forwarded product to another customer, please provide a copy of this letter to them.
-Please complete and FAX or e-mail the enclosed Reply Form (Appendix B the last page of this notice) within 10 days to confirm your receipt of this notice. Customers can contact Alere INRatio Recall Hotline by phone at 1-877-929-2579, for questions regarding this notification. Additionally, a website has been established providing information and frequently asked questions. www.inr-care.com
Please FAX or e-mail the completed Reply Form to:
Alere San Diego, Inc.
Fax: 1-877-929-2580
E-mail: Alere4319@stericycle.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Test, time, prothrombin - Product Code GJS
Causa
In certain cases, an inratio pt/inr monitor system may provide an inr result that is significantly lower than a result obtained using a reference inr system (laboratory method). this issue can arise if the patient has certain medical conditions. it can also occur if the instructions in the labeling for performing the test are not followed.
Acción
An Urgent: Medical Device Correction, dated December 5, 2014, was sent to Healthcare Professionals. The letter identified the affected product and reason for recall. Customers were instructed to:
-Ensure they have read and understand the precautions described in the current product labeling (a complete list of product labeling is provided in Appendix A) and the additional precautions in this notice describing medical conditions that may increase the risk of obtaining a (falsely or erroneously) lower than expected INR result. The INRatio PT/INR Monitor system should NOT be used if the patient has any of the medical conditions described.
-Verify that the patient has hematocrit within the range of 30% to 55%. If not, immediately transition the patient to an alternate INR monitoring method.
-Perform INR verification testing for the patients using a laboratory INR test method. Immediately transition any patient with a significantly discrepant low result on the INRatio¿¿ PT/INR Monitor system to an alternative INR monitoring method.
-If have forwarded product to another customer, please provide a copy of this letter to them.
-Please complete and FAX or e-mail the enclosed Reply Form (Appendix B the last page of this notice) within 10 days to confirm your receipt of this notice. Customers can contact Alere INRatio Recall Hotline by phone at 1-877-929-2579, for questions regarding this notification. Additionally, a website has been established providing information and frequently asked questions. www.inr-care.com
Please FAX or e-mail the completed Reply Form to:
Alere San Diego, Inc.
Fax: 1-877-929-2580
E-mail: Alere4319@stericycle.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Test, time, prothrombin - Product Code GJS
Causa
In certain cases, an inratio pt/inr monitor system may provide an inr result that is significantly lower than a result obtained using a reference inr system (laboratory method). this issue can arise if the patient has certain medical conditions. it can also occur if the instructions in the labeling for performing the test are not followed.
Acción
An Urgent: Medical Device Correction, dated December 5, 2014, was sent to Healthcare Professionals. The letter identified the affected product and reason for recall. Customers were instructed to:
-Ensure they have read and understand the precautions described in the current product labeling (a complete list of product labeling is provided in Appendix A) and the additional precautions in this notice describing medical conditions that may increase the risk of obtaining a (falsely or erroneously) lower than expected INR result. The INRatio PT/INR Monitor system should NOT be used if the patient has any of the medical conditions described.
-Verify that the patient has hematocrit within the range of 30% to 55%. If not, immediately transition the patient to an alternate INR monitoring method.
-Perform INR verification testing for the patients using a laboratory INR test method. Immediately transition any patient with a significantly discrepant low result on the INRatio¿¿ PT/INR Monitor system to an alternative INR monitoring method.
-If have forwarded product to another customer, please provide a copy of this letter to them.
-Please complete and FAX or e-mail the enclosed Reply Form (Appendix B the last page of this notice) within 10 days to confirm your receipt of this notice. Customers can contact Alere INRatio Recall Hotline by phone at 1-877-929-2579, for questions regarding this notification. Additionally, a website has been established providing information and frequently asked questions. www.inr-care.com
Please FAX or e-mail the completed Reply Form to:
Alere San Diego, Inc.
Fax: 1-877-929-2580
E-mail: Alere4319@stericycle.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Stent, carotid - Product Code NIM
Causa
Two production lots of the protege rx tapered carotid stent systems (secx-10-7-40-135, lot # 9922452 & sepx-8-6-40-135, lot # 9922795) because of a product labeling error.
Acción
Consignees were sent on 12/4/2014 a Covidien "Urgent Field Safety Notice" letter dated 4th December 2014. The letter described the problem and the product involved in the recall. Advised consignees to quarantine, discontinue use of the device and return the product to Covidien. They also requested consignees to complete the "Recall Verification Form" and return it to Covidien. For questions, customers can contact their local Covidien Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Instrument, Biopsy - Product Code KNW
Causa
There is the potential for a breach in the inner or outer packaging pouches of all lots of the stryker orthobiologics imbibe aliquot needle bone cement needle.
Acción
The firm, Stryker, sent an "URGENT PRODUCT RECALL" letter dated December 4, 2014, to end users/customers. The letter identified the product, problem, and actions to be taken. Customers were instructed to complete and return the URGENT MEDICAL DEVICE RECALL NOTIFICATION ACKNOWLEDGMENT FORM within 5 days via fax to 215-253-5020, contact other hospitals in your territory that have the affected products to arrange return of the product, and return the affected product to: Stryker Orthobiologics, 67 Great Valley Parkway, Malvern, PA 19355.
If you have any questions, feel free to contact the Associate Manager, Quality Assurance and Regulatory Compliance at 610-640-1775 x 5299.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Intervertebral fusion device with integrated fixation, cervical - Product Code OVE
Causa
A design deficiency was discovered whereby the drill/awl sleeve and spring-loaded drill/awl sleeve instruments ( the
sleeves ) allow the mating drill and awl instruments to penetrate 1.0 mm beyond their intended depths during screw hole preparation.
Acción
The firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated 11/11/2014 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and remove from circulation the items consigned/loaned to your account as identified; carefully follow the instructions on the enclosed "Response Form"; complete and return Response Form via fax to 303.501.8444, and if you have further distributed these items to medical facilities, you MUST notify them of the actions.
Questions related to this notice should be directed to the Sr. Quality Engineer at 518-859-3487 Monday through Friday, 8 am to 4 pm ET.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Two complaints reported that the biolox delta ts ceramic femoral articul/eze12/14 36mm +12 head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. the loosening refers to tissue tension and not the taper connection between the femoral head and stem. the investigations found that the small size sleeve (+1.5 femoral head offset) was incorrectly used in the.
Acción
On 11/7/2014, URGENT INFORMATION - RECALL NOTICE notifications were sent to the affected distributors, hospitals, and doctors with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospitals and doctors were notified via sales consultant visit. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc. Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m. - 5 p.m. EDT). For questions about device recall information provided, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. - 5 p.m. EDT).
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Light, surgical, fiberoptic - Product Code FST
Causa
Steris has learned that groups of led lights (modules) contained within the vled light head may illuminate inconsistently.
Acción
STERIS sent an Urgent Voluntary Field Correctionn Notice to all affected consignees via FedEx. The Consignee Notification mailing was initiated the week of December 15, 2014. Customers were instructed that their local STERIS representative would contact their facility to arrange for the installation of updated software. Customers with questions were instructed to call 1-800-548-4873.
For questions regarding this recall call 440-392-7231.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, x-ray, tomography, computed - Product Code JAK
Causa
There is a risk that during the transfer of an image and navigation data to the brainlab curve image guided surgery navigation system after a ct scan, an error may occur, causing either no navigation data or incorrect navigation data being transferred to the curve.
Acción
Mobius sent an Urgent Field Safety Notice dated December 8, 2014, to all affected customers. The letter explains the recall and provides advise on action to be taken by the user. The letter also informs consignees that Mobius Imaging is working on a software fix for the software bug/communication error. The final fix is anticipated in early 2015.
Advise on action to be taken by the user:
The user should be prepared for the potential necessity to perform a manual navigation registration in order to use navigation.
In general, do not use navigation data transmitted by the AIRO Mobile CT Scanner of any scan the Brainlab AIR App displayed the "Received Wrong Dataset" error for. To use such scans with the Curve, a manual
navigation registration is required.
To avoid the possibility of incorrect data from being transferred to the Curve, Mobius Imaging is recommending that customers only select "NO" when they come to the "Continue with same patient" screen after each scan. They can select the same patient under the "Existing Patients" tab and restart the workflow. Additionally, always adequately verify the accuracy of the navigation registration data as required by the Brainlab Curve" Navigation system software and the AERO Operator's Manual.
If you require further clarification, please feel free to contact your local Brain lab Customer Support
Representative.
Customer Hotline: +49 89 99 15 68 44 or +1800 597 5911 (for US customers) or by
E-mail: support@brainlab.com (for US customers: us.support@brainlab.com)
Fax Brainlab AG: + 49 89 99 15 68 33
Address: Brainlab AG (headquarters), Kapellenstrasse 12, 85622 Feldkirchen, Germany.
For questions regarding this recall call 978-615-5025.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Endoscope, Neurological - Product Code GWG
Causa
Cracked hubs/handles and/or improper peeling of the sheath during use.
Acción
Firm sent recall letters by Fedex on July 5, 2005 to all customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Sp02 and/or non invasive blood pressure (nbp) alarms may become disabled without visual notification.
Acción
The firm, Philips Healthcare, issued a "URGENT-Field Safety Notice" on 12/19/14 to inform customers of the issue, identify details of the units affected, instructs on actions to be taken by the customer and identify what action Philips plans to take to remedy the issue. Philips will provide a software correction free of charge.
Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice-To prevent this issue from occurring, customers/users should:
1) Disable the Change Bed Label field in Patient Management. This is accomplished by changing the feature from Optional to Hidden
2) All patient transfers must be performed using the Transfer key in the Manage Patient application.
Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment.
If you need any further information or support concerning this issue, please contact your local Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 with questions or concerns about this Device Correction.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Mrx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed.
Acción
Philips Healthcare issued on 12/23/14 The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue.
A software upgrade will be provided free of charge for all units affected by one or more of these issues. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade.
Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent
Medical Device Correction notification/Field Safety Notice:
You can continue to use your MRx prior to receiving the software upgrade.
If the MRx reboots during clinical use, continue to treat the patient according to your organizations protocol, reinitiating therapy if necessary.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Instrument, biopsy - Product Code KNW
Causa
There is the potential for a breach in the inner or outer packaging pouches of all lots of the imbibe bone marrow aspiration needle.
Acción
The firm, Stryker, sent an "URGENT PRODUCT RECALL" letter dated December 4, 2014, to end users/customers. The letter identified the product, problem, and actions to be taken. Customers were instructed to complete and return the URGENT MEDICAL DEVICE RECALL NOTIFICATION ACKNOWLEDGMENT FORM within 5 days via fax to 215-253-5020, contact other hospitals in your territory that have the affected products to arrange return of the product, and return the affected product to: Stryker Orthobiologics, 67 Great Valley Parkway, Malvern, PA 19355.
If you have any questions, feel free to contact the Associate Manager, Quality Assurance and Regulatory Compliance at 610-640-1775 x 5299.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
There are confirmed reports of a component coming loose inside the ct enclosure and damaging the system.
components.
Acción
The firm, Siemens, sent an undated "Customer Safety Advisory Notice" letter to all customers. The described the product, problem and actions to be taken. The letters inlcuded instructions for customers to: 1) continue to use their systems while waiting for the field correction to be scheduled and performed; 2) ensure that the safety advisory is placed in the system's instruction for use; and, 3) closely observe the patient during studies. The letter also instructs customers of record to forward a copy of the letter to the new owner if the equipment was sold or transferred.
Customers with any questions about this issue can contact Siemens Molecular Imaging at 800-888-7436 (US).
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Percussor, powered-electric - Product Code BYI
Causa
Customer notification that the device may be difficult to open or close.
Acción
Aptalis Pharmatech distributed a customer notification letter on November 13, 2014. The letter identified the affected product, problem and actions to be taken. Customers were instructed to forward complaints to Aptalis Pharmatech Customer Service department at 908-927-9600.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Test system, for drugs of abuse - Product Code MGX
Causa
This recall has been initiated due to potential false positives results when using the test to screen for ketamine. use of this product may give incorrect screening results.
Acción
Consignees were sent an Express Diagnostic Int. Inc., "Urgent" Letter dated 11//21/2014. The letter described the problem and the product involved in the recall. It advised consignees to quarantine the product. If the product has been further distributed, consignees were advised to notify their customers at once, Consignees were requested to complete and return the "Acknowledgement Form" either via fax to 1-507-526-2252 or e-mail Quality@drugcheck.com. For questions consignees can contact Jackie Gale, Director of Quality Systems and Regulatory Affairs at 1-507-526-3951.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Accelerator, linear, medical - Product Code IYE
Causa
Potential use error when the external gate controller is turned on after the vision rt software has been opened.
Acción
VisionRT sent an Urgent Medical Device Correction Notification letter dated November 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers shall:
A. Print the instructions in Appendix 3, place them in the front of the product guide and ensure these instructions are read and understood by all those who need to be aware of them within their organisation;
B. Maintain awareness of this issue until all actions indicated in this letter have been successfully completed;
C. Promptly inform Vision RT if they believe that patient harm occurred due to this issue; AND
D. Complete the acknowledgement in Appendix 1 and return it via email to corrections@visionrt.com.
Contact Vision RT
Should you have any queries on this letter, please do not hesitate to contact Vision RT by telephone on +44 20 83464300 (866 778-2379 from the US) or as per http://www.visionrt.com/contact/details.
For questions regarding this recall call 866-594-5443.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Immunohistochemistry reagents and kits - Product Code NJT
Causa
Three lots of mum-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.
Acción
Biocare sent a Medical Device Recall notifications letter to all customers by traceable method. The letters identified the affected product, problem and actions to be taken. Users are asked to immediately discontinue used of the affected lots and dispose of them according to applicable national, state and local laws. Users are requested to complete and return the response form so that proper credit can be issues
800-799-9499.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, x-ray, angiographic - Product Code IZI
Causa
In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.
Acción
Philips Medical Planned Action:
1. The affected customers will be sent a customer notification letter that identifies the software corrective actions and indicates that these corrective actions will be provided to the end-user free of charge
2. A mandatory Field Change Order with reference FCO72200270 will be released that requires Philips field service engineers to install Software release R7.2.8 which addresses the buzzer issue. The expected date of this FCO will be February 2015. The software release will contain updated timer function code to correct the intermittent fluoroscopy timer malfunction.
3. Philips Healthcare Field Service Engineers will schedule an appointment with customers to install the software update.
4. The software solutions will be rolled out consecutively, each within a maximum completion time of 6 months. The software releases will be corrected in descending order of the number of affected systems in the field, with approximately 80% of the total installed base corrected by 4 2015.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Some lots of pf4 concentrated wash (10x) are a slightly more dilute concentration. this may lead to slightly increased optical density (od) values. samples with a higher background reactivity may demonstrate false positive result (borderline reactivity) at or near the cutoff for the assay.
Acción
Immucor sent an Urgent - Field Safety Notice letter dated December 15, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to stop using the recalled product and to destroy it.
Requested consignees to complete the Customer Response From and return to waukeshatechsupport@immucor.com.
Please contact Technical Support should you need additional information at 262.754.1000 or waukeshatechsupport@immucor.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Complaints have indicated that the attune intuition impaction handle lever has fractured during impaction. if the lever fractures, there is the potential for fractured pieces of the device, or the inner spring, if released, to be left in the patient if not observed during surgery.
Acción
On 11/10/2014, URGENT INFORMATION ATTUNE INTUITION IMPACTION HANDLE AND IMPACTORS DEVICE CORRECTION NOTICE notifications were sent to the affected distributors and medical professionals. All distributors were notified via electronic mail, and all medical professionals with affected inventory were also notified by distributor or Sales Consultant via in person delivery or mail or electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. - 5 p.m. EDT).
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Interventional fluoroscopic x-ray system - Product Code OWB
Causa
Suboptimal routing of the cable may result in increased wear over time. without additional measures, damage of a cable may result in limited functionality and in rare cases, failure of a system. an ongoing procedure could be terminated in rare cases.
Acción
Siemens sent an important customer safety information notice, dated December 3, 2014, to all affected customers. The letter identified the product, problem, and action to be taken. The following hardware modifications will be implemented with the corrective action AX042/14/S:
1. A modified cable outlet to provide additional space for the cabling.
2. A modified plastic cover at the cable outlet providing optimal cable guidance in the area of the arc.
In general all systems will be checked for existing damage prior to the implementation of this action.
For questions regarding this recall call 610-219-6300.