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.
Integra lifesciences has identified through a small number of complaints that some lot numbers of licox test kits (catalog number bc10r) may provide erroneous "calibration test failure" message when they are used with the licox pto2 monitor (lcso2, or may provide an erroneous out of range result with the licox cmp brain tissue oxygen and temperature monitor (ac31).
Acción
Integra sent an "Urgent Voluntary Medical Device Recall/Return Response form notifications dated April 16, 2014 to US customers via traceable courrier service and to non-US customers via traceable email or facsimile. The customer notification advises them of the nature of the issue and the potential for adverse patient consequences; advises them to review their inventory and if they have BC10R Test Kit Resistors with an affected lot number to immediately stop using it; requests they identify and report to Integra if they do or do not have any affected BC10R affected lot numbers; and advises them how to return any affected products in their possession. Customers with questions were instructed to call 1-855-532-1723.
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
Introducer, catheter - Product Code DYB
Causa
Greatbatch identified that the documentation does not support the five-year shelf life of the bard access division coaxial micro-introducer set.
Acción
Greatbatch sent an "Urgent Medical Device Recall" letter dated April 25, 2014 to affected customers via email and Fedex. The letter described the Reason for Recall, Risk to Health, and Instructions to Customers. Requested consignees to immediately place affected devices in quarantine and to complete and return the Field Correction Action Response Form. For questions they should contact their local Greatbatch representative or 1-763-951-8235, or e-mail FieldActionCenter@Greatbatch.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.
This notice concerns a problem with the computation of roi voxel volumes for cases where the ct has variable slice spacing. the dose grid volumetric representation of an roi can be wrong. this affects all dose-volume properties for such rois, including dvh, dose statistics, clinical goals and constraints or objective functions. furthermore, if material override rois are used, or if the external is not represented by contours, the bug can trigger an error in the 3d dose distribution.
Acción
On April 25, 2014, RaySearch emailed all consignees of the affected product a copy of the recall notice as well as the response forms. Back up notification methods include phone calls and site visits.
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.
Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm), have been reported. this is caused by the development of high resistance on internal electrical connector contacts due to oxidation over time.
Acción
Consignees were sent a Medtronic "Urgent Medical Device Correction" letter dated April 2014. The letter was addressed to Risk Manger, Health Care Professional. The letter included the Issue Description, Root Cause, Potentially Affected 5348 EPGs within the Serial Number Ranges, Malfunction Indications, and Recommended Actions. For questions related to EPG service policy or purchasing a replacement EPG, customers should contact your Medtronic representative. For technical questions, please call Instruments Technical Service at (1-800)638-1991. Medtronic asks that customers complete and sign the attached Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality or e-mail to RS.CFOFCA@Medtrnic.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
Gram-Negative bacteria and associated resistance markers - Product Code PEN
Causa
Nanosphere has determined that a portion of bc-gn test cartridge lot number 040214021a has an elevated risk for no call results and false negative results. the bc-gn test cartridge (20-006-021) is distributed as part of the verigene bc-gn test kit (20-005-021), which is labeled as "ivd". therefore, nanosphere has initiated a voluntary recall to retrieve the following bc-gn test cartridges: test ca.
Acción
All customers were initially notified of the recall by telephone on April 17, 2014. The customers were instructed to quarantine and return all affected product to Nanosphere.
Nanosphere sent an Voluntary Product Recall Notification letter dated April 17, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The letters included instructions: 1) on how to return the recalled products, and 2) to review any test results that were generated while using the recalled products to ensure that there has been no negative impact on patient care. Customers with questions can contact Nanosphere at 888-837-4436, option 2 or via e-mail at Technicalsupport@nanosphere.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
Bit, surgical - Product Code GFG
Causa
Certain lots of the prodisc-c 2.0mm milling bits have an increased potential to break during use.
Acción
DePuy Synthes sent a Recall letter, dated April 29, 2014, to affected customers. The letter identified the affected customers, problem and actions to be taken. The letter instructed customers to discontinue use and distribution of the device and to return affected devices to 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.
Software issues with acuson sc2000 ultrasound with software version 3/5 (va35) - may incorrectly display the color flow data in the wrong position and when doppler frequency is adjusted, the system does not restart the pulsed wave doppler or continuous wave doppler waveform.
Acción
Siemens sent an Customer Safety Advisory Notification letter on April 23, 2014, to all affected customers. Distributors in foreign countries will implement delivery of notification to their customers.
" Use the factory default presets with software version 3.5 instead of user-defined presets restored from software version 2.0
or 3.0. Review all patient studies on exams performed after software revision 3.5 was installed on your system. If you are unsure when this software was installed on your system, please contact your local Customer Service representative.
" After adjusting the Doppler frequency, freeze and unfreeze the system. This action refreshes the display of the Doppler spectrum resulting in accurate measurements. Additional measurements performed after system freeze results in correct measurement values.
Your local Customer Service Engineer will contact you to schedule an appointment to replace your existing version of software, free of charge. If you have any questions, please contact your local service support person for
information regarding timelines and status.
Until the new software has been installed on your system, please share this information with all personnel within your organization who need to be aware of this issue. As always, patient safety issues are a high priority, and we alert customers of product concerns which may occur under various conditions. To date, no patient injury has been reported as a result of these issues.
We sincerely regret any inconvenience this condition may cause in your daily operations. For further questions call (650) 694-5398.
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.
Potential malfunction due to a software issue for acuson sc2000 ultrasound systems using software version 3.5 (va35) when using the stress echo feature which could cause the need for the study to be repeated.
Acción
Siemens sent a Consumer Safety Advisory Notification letter on April 23, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the stress echo feature with software version .5. For studies acquired with systolic-only captures: review all patient studies on exams performed after software revision 3.5 was installed on your system. If you are unsure when this software was installed on your system,
please contact your local Customer Service representative. Foreign distributors will implement distribution of the field correction to their customers.
For questions regarding this recall call 650-694-5398.
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.
Failure to effectively install and test a hotfix to correct the known software defect within the impax cv 7.8 su3-ocr service.
Acción
AGFA Healthcare sent an URGENT FIELD SAFETY NOTICE LETTER dated April 30, 2014, to the consignee describing the problem that had occurred, the actions being taken by Agfa and the actions Agfa has required the site to perform. As part of the correction Agfa requires the consignee to review the affected reports to confirm that the data is correct. If errors are found the consignee will need to correct the data. The consignee was asked to acknowledge, via FAX-Back to 864-421-1664 or email, that the information was received and understood by the consignee. For questions the consignee was instructed to contact their local Agfa HealthCare organization at 877-777-2432.
For questions regarding this recall call 864-421-1754.
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, nuclear magnetic resonance imaging - Product Code LNH
Causa
Siemens discovered a processing error for the magnetom aera magnetic resonance system that may have resulted in some users not receiving operator manuals.
Acción
A customer safety advisory notice, dated April 24, 2014 was sent to notify direct accounts of the delivery of user manuals.
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 nitinol wire or monofilament may buckle within the ezpass suture passer and become kinked making the wire/monofilament difficult to use.
Acción
On 2/28/14, customers received a letter stating these devices have been recalled following an investigation which identified that the nitinol wire or monofilament may buckle within the EzPass Suture Passer and become kinked making the wire/monofilament difficult to use. The letter also stated, there is no adverse health outcome expected for the patient and this action requires the immediate location and discontinued use of the product and its return to Biomet.
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 nitinol wire or monofilament may buckle within the ezpass suture passer and become kinked making the wire/monofilament difficult to use.
Acción
On 2/28/14, customers received a letter stating these devices have been recalled following an investigation which identified that the nitinol wire or monofilament may buckle within the EzPass Suture Passer and become kinked making the wire/monofilament difficult to use. The letter also stated, there is no adverse health outcome expected for the patient and this action requires the immediate location and discontinued use of the product and its return to Biomet.
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
Passer - Product Code HWQ
Causa
The nitinol wire or monofilament may buckle within the ezpass suture passer and become kinked making the wire/monofilament difficult to use.
Acción
On 2/28/14, customers received a letter stating these devices have been recalled following an investigation which identified that the nitinol wire or monofilament may buckle within the EzPass Suture Passer and become kinked making the wire/monofilament difficult to use. The letter also stated, there is no adverse health outcome expected for the patient and this action requires the immediate location and discontinued use of the product and its return to Biomet.
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 customer reported that the table top had become free floating. a field service engineer (fse) confirmed that the service latch had become disengaged.
Acción
Philips Healthcare sent an Urgent Medical Device Correction letter dated April 1, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed If they experience a horizontal, free-floating couch motion, to contact their Field Service Engineer immediately. Customers were instructed to retain a copy of this Field Safety Notice with the equipment Instructions for
USER Use (IFU). Customers with questions or needing further information were instructed to contact their local Philips representataive or local Philips Healthcare office. For North America, contact the Customer Care Solutions Center at 1-800-722-9377, Option 5.
For questions regarding this recall call 440-483-3032.
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
Varnish, cavity - Product Code LBH
Causa
The firm discovered that the gluma desensitizer power gel can be inadvertently extruded from the application syringe all at once when it is supposed to extrude on the desired area a small amount at a
time. if extruded all at once, product could reach the dental patients mucosa, face or eyes or the dental professional could be exposed. this would cause irritation, burning or blistering.
Acción
Heraeus Kulzer sent a Voluntary Recall letter dated April 22, 2014 to all affected doctors and supply centers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to:
1. Inspect your inventory, both in storage and in use, and identify the lot number on your kits and syringes. Refer to attached images.
2. If you identify any Gluma Desensitizer PowerGel with the aforementioned kit or syringe lot numbers, immediately cease usage of this product and call Technical Services at 1 (574) 299-5409
3. Please advise if you forwarded this product to any other end users. We will need their contact information inClusive of name, address and phone number.
For questions regarding this notification, please call our Technical Service team at (574) 299-5409.
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
Full field digital,system,x-ray,mammographic - Product Code MUE
Causa
There is a potential and possible hazard to the user when using the mammomat inspiration pc monitor at the control desk, in that the holder of the pc monitor can break causing an unstable monitor to fall causing possible serious injury.
Acción
A safety advisory notice, dated April 25, 2014, was sent to direct accounts to notify them of the issue and provide instructions to avoid the potential risk of injury.
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
Monitor, apnea, home use - Product Code NPF
Causa
The battery pack wire harness is improperly assembled rendering the device inoperable. the wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up. the presence of the error code and the devices alarm prevents the device from functioning until the issue is addressed.
Acción
Philips sent an Urgent Medical Device Correction letter dated April 29, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
This Customer Information is intended to inform you about:
1.what the problem is and under what circumstances it can occur
2.the actions that you as a customer can take to minimize the effect of the problem
3.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: For further questions please call (412) 380-8881.
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
Urine collection kit (excludes hiv testing) - Product Code OIE
Causa
Incorrect labeling was used on each pouch of the affected lots of aptima urine specimen collection kits. the outer box of the kits are identified correctly as "aptima urine collection kits"; however, the inner pouches are incorrectly labeled as "aptima unisex swab collection kit for endocervical and male urethral swab specimens.".
Acción
Hologic sent a Recall Notice letter dated April 14, 2014 via overnight mail (FedEx) to affected customers. The letter identified the affected product, problem and actions to be taken. The notification letter requests customers to: 1. segregate the entire contents of the affected kit lots
2. reconcile and destroy all partial and/or full kits remaining in inventory and to document; the amount destroyed on the Customer Response Form provided with the Recall Notice; 3. if the urine collection kits were further distributed to other collection sites, then to notify them of this issue; and 4. complete and return the Customer Response Form to Technical Support (contact information is provided in the notification letter).
For additional information, questions, or concerns, contact Hologic Molecular (Technical) Support.
Toll Free: 888-484-4747
Direct: 858-410-8511
Fax: 858-410-8250
Email: molecularsupport@hologic.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
Device, pasteurization, hot water - Product Code LDS
Causa
Cenorin llc is voluntarily recalling hld systems model 610 washer/high level disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction.
Acción
Cenorin sent a letter on April 24, 2014 informing their customers of the potential failure of the pump. This letter also explains the customer's option of upgrading their entire HLD System to the new cleaning fluid delivery system or to continue purchasing a six month PM kit that has a replacement pump added.
Customers are instructed to complete and return an enclosed response form within 15 days and to email Jamie Wright at jwright@cenorin.com or call 800-426-1042, extension 224 for questions.