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
Accessories, germicide, cleaning, for endoscopes - Product Code NZA
Causa
The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on the listed fujinon g5 & g8 type flexible gi endoscopes does not connect to the main air/water channel within the light guide (lg) connection head and, as a result, the air pipe does not receive forced flow during the reliance eps processing cycle.
Acción
Steris sent an "URGENT PRODUCT SAFETY NOTICE" dated September 5, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the 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.
Notas adicionales en la data
Gas-machine, anesthesia - Product Code BSZ
Causa
Ge healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the engstr¿m ventilator and the aespire view, aisys, and avance anesthesia machines.
as a result of a manufacturing issue, the buttons on the left, right, and bottom keypads may not always detect button presses. this may result in the inability to access certain menu functions wh.
Acción
Consignees were sent on 8/28/2013 a GE Healthcare "Urgent Medical device Correction" letter dated August 28, 2013. The letter was addressed to Chief of Anesthesia, Health Care Administrator / Risk Manager and director of Biomedical / clinical engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (1-800-345-2700 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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Pump, infusion - Product Code FRN
Causa
Hospira shipped the incorrect replaceable battery pack (part no: hsp3566-e10) instead of the correct e09 battery pack (part no. hsp3566-e09) for the symbiq single and dual channel infusers.
Acción
The firm, Hospira, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated August 28, 2013 to its customers. Hospira contracted with Stericycle, Inc., in Indianapolis, IN for customer notification, response, tracking, returns, effectiveness checks and destruction of returned product starting on August 28, 2013. The letter described the product, problem and actions to be taken. Customers were instructed to: 1) complete and return the attached reply form via fax to 1-866-470-3291 or e-mail to Hospira2921@stericycle.com, even if you do not currently have the affected batteries; 2) contact Stericycle at 1-877-779-7810 (M-F, 8am - 5pm ET) if they require additional response forms; and, 3) return any affected batteries upon receipt of the new (correct) replacement batteries to Stericycle. Customers are also instructed to forward the recall information to any accounts that they may have shipped the affected batteries to and have them contact Stericycle to recieve a reply form and return label.
For further inquiries, please contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 6, availabel 24 hours a day/7 days per week.
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
Filler, bone void, calcium compound - Product Code MQV
Causa
The sterility of this product to a sterility assurance level (sal) of 10(-6) cannot be assured.
Acción
Globus sent an Urgent: Medical Device Recall Notification letter, dated August 28, 2013 to customers/users. The letter identified the affected units, issue, potential risk, product, and actions to be taken. Customers were requested to complete the attached response card and return of the affected product to Globus Medical. For questions and support contact Globus Medical by fax 1-610-300-1342 or email:recall@globusmedical.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.
Siemens sent an Urgent Medical Device Recall letter dated August 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use of the affected product. Siemens will replace unused affected product at no charge. For replacements customers were instructed to incude this information on the Effectiveness Check form included with the letter. The Effectiveness Check form must be returned even if no replacement reagents are needed. The recall letter was to be retained with customers laboratory records and forwarded to those who may have received this product. Customers with questions were instructed to contact Siemens Technical Solutions or their Siemens technical support representative.
For questions regarding this recall call 800-441-9250.
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
Screw, fixation, bone - Product Code HWC
Causa
Polaris translation screw failures were recently reported to biomet spine. these failures are generally described as dissociation of the screw head from the shaft of the polaris translation screw.
Acción
Urgent Product Information notices dated 8/22/2013 were mailed via FedEx to distributors on 8/23/2013. Follow-up emails with a copy of the UPI notice were sent to distributors on 8/23/2013. The UPI notice informed the customers of the issue with the product and how to identify the affected product. Customers were advised that the Polaris Translation Screw System and the SpF Implantable Spine Fusion Stimulator not be used in conjunction with any implants containing cobalt chrome. Firm contacts were provided in case customers had any questions. EBI, LLC had a conference call with their domestic distributors on 8/23/2013 informing them they are required to notify their 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.
Ge healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle.
there is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. this issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the on p.
Acción
GE Healthcare sent an "Urgent Medical Device Correction" letter dated August 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were requested to inspect your power assist handle for either of the two conditions listed below. Immediately contact your local GE Healthcare Service Representative if any issue is found.
1. If you observe that the power assist handle plastic grip is loose relative to
the mount, discontinue use.
2. If plastic grip is secure, but you observe erratic performance, (power assist
unresponsive, drifting of spotfilm device with no command, or lock release
always ON), you may continue to use the device with care. Use all safety
precautions relative to application of the myelographic stop and the inhibit,
table horizontal stop OFF.
GE Healthcare will correct all affected systems at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction.
If you have any questions or concerns regarding this notification, please call one of the following phone numbers:
United States: 800 437 1171
Japan: 0120 055 919
For other countries, please contact your local GE Healthcare Service 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
Gas-machine, anesthesia - Product Code BSZ
Causa
There was an occurrence where the patient case data did not match the patient data when the case was recalled in the anesthesia care record (acr) in that it included data from another case.
Acción
McKesson sent a Clinical Alert dated March 15, 2013 to all affected customers. Additionally, phone calls were placed to each customer, followed up by an email to provide them written copies of the communication and Clinical Alert and obtaining acknowledgement that they have read and understand the issue and preventive actions to take. Customers with questions were instructed to contact McKesson Customer Support at 800-442-6767 (option 3).
For questions regarding this recall call 404-338-3556.
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
Gastroscope and accessories, flexible/rigid - Product Code FDS
Causa
A limited number of endoscopes were shipped to fmsu-esd with a manufacturing defect which included missing set screws used to more securely attach the forceps inlet (biopsy inlet port) to the endoscope.
Acción
The firm, FUJIFILM Medical Systems, USA, Inc. (FMSU-ESD) sent an "URGENT-MEDICAL DEVICE CORRECTION (UMDC)" and Customer Acknowledgement forms dated July 31, 2013 to their customers. The letter described the issue with the affected product; instructed customers on how to identify affected units; instructed customers to immediately cease use of the affected units; return affected units to FMSU-ESD for repairs and quality control inspection; and complete and return the attached "Customers Acknowledgement" form to FMSU-ESD, Attn: Regulatory Compliance, via fax to (973) 686-2616 or email: gwalljasper@fujifilm.com.
If you have any questions regarding this notice, please do not hesitate to contact Director, Quality and Regulatory Compliance, at (973) 686-2636 or by email: gwalljasper@fujifilm.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
System, x-ray, tomography, computed - Product Code JAK
Causa
There are artifacts appearing on the tracker images during threshold-triggered bolus scans with protocols using a rotation time of 0.4 seconds.
Acción
Philips sent an "Urgent - Medical Device Correction" letter dated August 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
This Field Safety Notice is intended to inform you about:
" what the problem is and under what circumstances it can occur
" the actions that should be taken by the customer / user in order to prevent risks for patients or users
" the actions planned by Philips to correct the problem
If you need any further information or Support concerning this issue, please contact your local Philips representative or local Philips Healthcare office.
For North America and Canada, contact the Customer Care Solutions Center
(1 -800-722-9377, Option 5: Enter Site ID or follow the prompts).
This notice has been reported to the appropriate Regulatory Agency.
Philips apologizes for any inconveniences caused by this problem
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
Plate, fixation, bone - Product Code HRS
Causa
A complaint was reported regarding a screw being found in a package labeled for 2.4 mm lc-dcp plate.
Acción
Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory, immediately remove the affected product and return to Credit/Returns, Synthes. For questions call 610-719-5450.
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, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
Causa
The fse image upgrade kit (part 92019c) is recalled due to issue related to the export of data from the evolis analyzer to laboratory information systems (lis) when using the monolisa anti-hbs eia
quantitative determination in evolis apf version 6.0.
Acción
BioRad has sent an Urgent Product Correction letter dated August 19, 2013, to customers who had the EVOLIS FSE Upgrade Image Kit installed on the EVOLIS at their site by a Bio-Rad Laboratories Field Service Engineer (FSE).
This issue impacts laboratory only if you are running the MONOLISA Anti-HBs EIA Quantitative Determination method with EVOLIS APF version 6.0 and TimeLiner Data Management Software. If you use this Quantitative Determination method with EVOLIS APF version 6.0, please contact Bio-Rad Laboratories for additional information or assistance.
Bio-Rad Laboratories is currently developing and qualifying a software update CD consisting of the EVOLIS APF V6.0b and Timeliner Data Management Software to correct the issue. The software update CD will be installed by Bio-Rad Field Service Engineers at each of the customer sites when
installing the EVOLIS APF V6.0b.
Customers should contact Bio-Rad Laboratories at 1-800-224-6723, Option
2 and then Option 3 for any questions about this product 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.
Notas adicionales en la data
System, x-ray, tomography, computed - Product Code JAK
Causa
The doseright feature suggest a mas based on the measured patient size, a reference size and a reference mas. when scanning large children, the suggested mas may be higher than clinicians would expect.
Acción
Philips Medical Systems sent a Field Safety Notice letter dated February 25, 2011, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customers.
Your Corrective Action Plan (CAP) is approved and consists of:
1. Notifying all affected users with Field Safety Notice 72800527/72800528 starting March 8, 2011. This Field Safety Notice has been reviewed and is approved.
2. Following up with all responses by dispatching a Field Service engineer to each site to install the software update at no cost to the user.
3. Tracking the responses from users by certified mail.
For further questions please call (440) 483-7600.
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, stationary - Product Code KPR
Causa
When using systems operating with software versions vd10a/g during a rad examination, a malfunction can result in the image appearing very dark, which may prompt unnecessary repetition of the examination.
Acción
Siemens sent a notification letter, dated August 28, 2013, to Affected customers. The letter identified the affected product, problem and actions to be taken. The letter provided work-around instructions and announced that a field modification was prepared to resolve the issue.
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.
The tyvek(tm) lid on one, or both, of the two trays that form a
double barrier around the insert may not have been adequately sealed.
Acción
Smith & Nephew sent an Urgent Recall Notification letter dated August 27, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. They were instructed to cease use and distribution of the product and quarantine for return. Customers were instructed to contact Smith & Nephew via email at FieldActions@smith-nephew.com or fax 901-566-7975 to obtain a return authorization (RA) number. Customers with questions were also instructed use this email address. Customers with affected product were instructed to return it along with the completed inventory Return Certification Form to the address listed on the form. Non-responding consignees were notified again on September 27, 2013, by email.
For questions regarding this recall call 901-396-2121.
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.
The tyvek(tm) lid on one, or both, of the two trays that form a
double barrier around the insert may not have been adequately sealed.
Acción
Smith & Nephew sent an Urgent Recall Notification letter dated August 27, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. They were instructed to cease use and distribution of the product and quarantine for return. Customers were instructed to contact Smith & Nephew via email at FieldActions@smith-nephew.com or fax 901-566-7975 to obtain a return authorization (RA) number. Customers with questions were also instructed use this email address. Customers with affected product were instructed to return it along with the completed inventory Return Certification Form to the address listed on the form. Non-responding consignees were notified again on September 27, 2013, by email.
For questions regarding this recall call 901-396-2121.
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.
The tyvek(tm) lid on one, or both, of the two trays that form a
double barrier around the insert may not have been adequately sealed.
Acción
Smith & Nephew sent an Urgent Recall Notification letter dated August 27, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. They were instructed to cease use and distribution of the product and quarantine for return. Customers were instructed to contact Smith & Nephew via email at FieldActions@smith-nephew.com or fax 901-566-7975 to obtain a return authorization (RA) number. Customers with questions were also instructed use this email address. Customers with affected product were instructed to return it along with the completed inventory Return Certification Form to the address listed on the form. Non-responding consignees were notified again on September 27, 2013, by email.
For questions regarding this recall call 901-396-2121.
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.
The tyvek(tm) lid on one, or both, of the two trays that form a
double barrier around the insert may not have been adequately sealed.
Acción
Smith & Nephew sent an Urgent Recall Notification letter dated August 27, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. They were instructed to cease use and distribution of the product and quarantine for return. Customers were instructed to contact Smith & Nephew via email at FieldActions@smith-nephew.com or fax 901-566-7975 to obtain a return authorization (RA) number. Customers with questions were also instructed use this email address. Customers with affected product were instructed to return it along with the completed inventory Return Certification Form to the address listed on the form. Non-responding consignees were notified again on September 27, 2013, by email.
For questions regarding this recall call 901-396-2121.
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.
The tyvek(tm) lid on one, or both, of the two trays that form a
double barrier around the insert may not have been adequately sealed.
Acción
Smith & Nephew sent an Urgent Recall Notification letter dated August 27, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. They were instructed to cease use and distribution of the product and quarantine for return. Customers were instructed to contact Smith & Nephew via email at FieldActions@smith-nephew.com or fax 901-566-7975 to obtain a return authorization (RA) number. Customers with questions were also instructed use this email address. Customers with affected product were instructed to return it along with the completed inventory Return Certification Form to the address listed on the form. Non-responding consignees were notified again on September 27, 2013, by email.
For questions regarding this recall call 901-396-2121.
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.
The tyvek(tm) lid on one, or both, of the two trays that form a
double barrier around the insert may not have been adequately sealed.
Acción
Smith & Nephew sent an Urgent Recall Notification letter dated August 27, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. They were instructed to cease use and distribution of the product and quarantine for return. Customers were instructed to contact Smith & Nephew via email at FieldActions@smith-nephew.com or fax 901-566-7975 to obtain a return authorization (RA) number. Customers with questions were also instructed use this email address. Customers with affected product were instructed to return it along with the completed inventory Return Certification Form to the address listed on the form. Non-responding consignees were notified again on September 27, 2013, by email.
For questions regarding this recall call 901-396-2121.
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
There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the artis q and artis q biplane systems with a flat detector as 40 hdr (large 30x40).
Acción
Siemens sent an Important Customer Safety Notice letter dated November 22, 2013, to affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to discontinue use until the affected product has been successfully replaced by a Siemen's representative.at no cost.
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
A description of the defect in the product or the manner in which the product fails to comply with an applicable federal standard; the minicat ct scanners subject to this notification failed to meet xoran's specifications for dose rate of 125 ¿¿ 3 kvp. these 18 complaints received include dose rates both on the high and low end of xoran's specifications. see attachment 1 for details. (e) a n evalu.
Acción
All of the MiniCAT CT Scanners subject to these complaints were serviced by Xoran technicians and the out-of-specifications devices were brought into specification. This was accomplished by either readjusting the settings or by installing a new component.
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
A description of the defect in the product or the manner in which the product fails to comply wvith an applicable federal standard; the minicat ct scanners subject to this notification failed to meet xoran's specifications for dose rate of 125 ¿ 3 kvp. these 18 complaints received include dose rates both on the high and low end of xoran's specifications. see attachment 1 for details. (e) a n evalu.
Acción
All of the MiniCAT CT Scanners subject to these complaints were serviced by Xoran technicians and the out-of-specifications devices were brought into specification. This was accomplished by either readjusting the settings or by installing a new component. Xoran's Research & Development group is evaluating the current specification to see if the field specifications are appropriate and to ensure that proper testing protocols are communicated and are in place for use by 3 rd party testing organizations. In addition, Xoran has initiated CAPA # 18 0 that is looking at the source block with regard to evaluating the stability of the dose rating.
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
The minicat ct scanners subject to this notification failed to meet xoran's specifications for dose rate of 125 ¿ 3 kvp. these 18 complaints received include dose rates both on the high and low end of xoran's specifications. see attachment 1 for details. (e) a n evaluation of the hazards reasonably related to defect or the failure to comply with the federal standard; an evaluation of the health ha.
Acción
All of the MiniCAT CT Scanners subject to these complaints were serviced by Xoran technicians and the out-of-specifications devices were brought into specification. This was accomplished by either readjusting the settings or by installing a new component. Xoran's Research & Development group is evaluating the current specification to see if the field specifications are appropriate and to ensure that proper testing protocols are communicated and are in place for use by 3 rd party testing organizations. In addition, Xoran has initiated CAPA # 18 0 that is looking at the source block with regard to evaluating the stability of the dose rating.
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
The minicat ct scanners subject to this notification failed to meet xoran's specifications for dose rate of 125 ¿ 3 kvp. these 18 complaints received include dose rates both on the high and low end of xoran's specifications. see attachment 1 for details. (e) a n evaluation of the hazards reasonably related to defect or the failure to comply with the federal standard; an evaluation of the health ha.
Acción
All of the MiniCAT CT Scanners subject to these complaints were serviced by Xoran technicians and the out-of-specifications devices were brought into specification. This was accomplished by either readjusting the settings or by installing a new component. Xoran's Research & Development group is evaluating the current specification to see if the field specifications are appropriate and to ensure that proper testing protocols are communicated and are in place for use by 3 rd party testing organizations. In addition, Xoran has initiated CAPA # 18 0 that is looking at the source block with regard to evaluating the stability of the dose rating.