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.
Torque wrenches used to tighten certain psc bolts were out of calibration. this could lead to over- or under-tightening of bolts that may result in system faults, mechanical sound (e.G. scraping, squeaking, rattling), cracks or vibration in the system.
Acción
Intuitive sent an Urgent Medical Device Correction letter dated May 13, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. All personnel who use the device should be notified of the issue and the acknowledgement form completed and returned.
Intuitive reps will visit each affect sites to install a replacement PSC and ensure that it is properly integrated with the Da Vinci.
For questions contact Intuitive Surgical at 800-876-1310 Option 3 (Monday - Friday 6 am to 5 pm PST).
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-positive bacteria and their resistance markers - Product Code PAM
Causa
Biofire has identified an increased risk of false positive results when the filmarray blood culture identification (bcid) panel is used with biom¿rieux bact/alert standard anaerobic (sn) blood culture bottles. false positive results have been observed for pseudomonas aeruginosa and enterococcus.
Acción
BioFire Diagnostics sent an Urgent Recall/Correction letter on May 28, 2014. Customers were instructed If the BCID Panel is used to test BacT/ALERT SN bottles, positive results for Pseudomonas aeruginosa and Enterococcus should be confirmed by another method prior to reporting the test results.
Customer with questions were instructed contact customer support at Support@biofiredx.com or via telephone by dialing 1-800-735-6544 and selecting option 5 for customer support and then option 1 for FilmArray.
For questions regarding this recall call 801-736-6354, ext 360.
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 has identified through an investigation of complaints that there may be the potential for the tip of a
single lot number of the ucr 3mm hex, large axial driver, 91-1123 to twist or become rounded during
use.
Acción
Integra sent an Urgent Voluntary Medical Device Recall letter dated May 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed:
1. If you have distributed the affected product, identify those customers and forward the attached Integra Medical Device Recall Notice to them.
2. Inspect your inventory of UCR 3mm Hex, Large Axial Drivers (Catalogue Number: 91- 1123). If you have product with lot number MO16090B, STOP USING IMMEDIATELY. If you have product of any other lot number, you can continue to use it. The event has been isolated to this single lot.
3. We also request that regardless if you have a UCR Driver with the affected lot, you complete the attached form and return it to us as soon as possible as indicated. We recommend you keep a copy of the form for your records.
4. When your form is received, Customer Service will contact you and provide an RMA number, directions to return the product, and input an order to replace the quantity you indicate on the form.
Should you have any questions regarding these instructions, please contact Customer Service at 1-866- 942-8698.
We apologize for any inconvenience this may cause and thank you for your cooperation in this effort.
:
.
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
Solid state x-ray imager - Product Code MQB
Causa
Although the flat panel detector (fpd) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, the movement of longitudinal tilt does not stop.
Acción
Toshiba America Medical Systems, Inc. initiated this recall by sending recall notifications via USPS return receipt mail.
The recall notification letter, dated May 12, 2014, titled "URGENT: MEDICAL DEVICE CORRECTION", informed customers of the following: device information, serial number, SID, reason for reason, purpose of the notification, corrective action, request to customers, contact information, and customer reply form.
Customers with questions regarding this letter were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.
For questions regarding this recall call 714-730-5000.
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
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
Causa
Some units of intella tip mifi xp temperature ablation catheters were not manufactured according to specification.
Acción
Customers were informed of the recall via overnight letter sent on May 15, 2014.
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
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
Causa
Some units of intella tip mifi xp temperature ablation catheters were not manufactured according to specification.
Acción
Customers were informed of the recall via overnight letter sent on May 15, 2014.
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
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
Causa
Some units of intella tip mifi xp temperature ablation catheters were not manufactured according to specification.
Acción
Customers were informed of the recall via overnight letter sent on May 15, 2014.
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
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
Causa
Some units of intella tip mifi xp temperature ablation catheters were not manufactured according to specification.
Acción
Customers were informed of the recall via overnight letter sent on May 15, 2014.
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
Oximeter - Product Code DQA
Causa
Spacelabs healthcare is voluntarily recalling the hamilton galileo ventilator flexport, model 90436a-07, where the monitored minute volumes (vmin) has been reported at one time to reach ten times the actual value on the bedside monitor.
Acción
Spacelabs changed their strategy for updating the software and sent the updated letter Urgent-Medical Device Correction- Hamilton Galileo Ventilator Flexport
Model 90436A-07, dated 10 June 2015, to their consignees.
The firm is going to send consignees new replacement flexport(s) with upgraded software and requested consignees to return old affected units via Return Goods Authorization (RGA) to Spacelabs and the firm will destroy affected units.
Consignees are instructed to take the following actions:
1. Please replace the affected devices and test for correct operation.
2. Return your old device(s) using the RGA number and prepaid FedX shipping label.
Use the Reference code: and FedEx Return number:
RETURN ADDRESS:
Spacelabs Healthcare, Inc.
35301 SE Center St.
Snoqualmie, WA 98065
(425) 363-5816
If you have any questions about this corrective action program, please call Spacelabs Healthcare at (800) 522-7025 and select 2 for Technical Support.
**********************************************************************************************
Spacelabs recommends that customers immediately advise their staff of this situation and if they continue to use the Flexport, to please keep in mind:
1) Galileo Interface Protocol (GIP) version 1.0 and 1.1 do not affect the flexport readings. Only GIP version 1.2 is an issue.
2) If you have the GIP version 1.2:
-The ventilator alarms continue to work normally at the bedside and central station.
-The ventilator itself is available and working correctly.
-The reported x10 volumes would be an obvious error to the clinician.
Spacelabs Field Service personnel will be contacting all customers to schedule a convenient time to install, at no cost, a software update that resolves this 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.
Possible sound loss associated with the carescape monitor b650. when an external display is connected to the carescape monitor b650 using a usb extender cable with an active usb hub, the system may experience a sound loss including alarm sounds from the patient monitor. this may occur if the external display is powered off and on during normal operation of the monitor.
Acción
GE Healthcare "Urgent Medical Device Correction" letter #36102 dated July 7, 2014 to affected customers. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions they can contact Technical Support at 1-800-558-7044 or your local 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
Accelerator, linear, medical - Product Code IYE
Causa
There is a potential risk when using lantis ois system client software with operating systems for which it has not been validated and released, resulting in incorrectly stored data, such as treatment records, and lantis database corruption.
Acción
Siemens sent an Urgent Medical Device Correction Field Safety Notice dated was sent to end users on/about May 6, 2014, to notify them of the safety issue and provide instructions to avoid potential risks. Customers were instructed to make sure all computers with the LANTIS client software installed are running on an operating system that was validated by Siemens for opration with LANTIS, e.g. Microsoft Windows XP Service Pack 3 (SP3). Customers were asked to include the Field Safety Notice in their System Owner Manual chapter "Safety Advisory Letters" where it should remain and that all affected personnel affected be informed.
For questions regarding this recall call 1-610-219-6300.
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, mobile - Product Code IZL
Causa
There is a potential fire hazard of certain lithium-ion batteries in the computers used in the original manufacturing or as spare parts between october 2010 and april 2011 for the siemens mobilett xp digital mobile x-ray system, which might occur at any time with higher probability while the system is being charged and connected to the main power supply.
Acción
Siemens sent a Safety Advisory Notice letter dated May 9, 2014, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that a Siemens service technician would be visiting their site to identify and service affected devices.
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, for manual surgical instrument - Product Code HWC
Causa
All lots of b37 replacement screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label.
Acción
An urgent medical device recall notice, dated May 29, 2014, was sent to end users and sales consultants to advise them of the issue and provide instructions for returning affected devices.
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, radiation therapy, charged-particle, medical - Product Code LHN
Causa
Anomaly with the probeam system where under certain conditions, the treatment control and monitoring application could fail to send treatment history records to the aria database.
Acción
Varian sen an Urgent Device Medical Correction/Urgennt Field Safety Notice letter dated May 9, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions cotact Varian Service Support. at debg-PT-service-support@varian.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.
Although the natural rubber latex caution symbol is clearly
displayed on the product label, the accompanying caution statement "caution: this product contains natural rubber latex which may cause allergic reactions" was not printed on the product label.
Acción
Teleflex Medical sent a Urgent Medical Device Recall Notification dated June 6, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Our records indicate that you have received products that are subject to this recall. We are now notifying our customers to take the following actions:
1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed above from the lot numbers listed on the attachment.
2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-866- 804-9881, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical.
3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. This will allow us to document your receipt of this letter.
Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
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
Mosaiq does not re-calculate the agent volume when the user changes the ordering dose (to other than what was calculated) prior to saving the order.
Acción
Elekta issued an Important Safety Notice dated May 29, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Corrective action that shall be taken:
Notify the affected customers of the issue - To be completed 06/22/2014
Follow up with the affected customers for:
Confirmation receipt of the LIN, AND
Confirmation of installation of patch for the fix- To be completed 11/30/2014
The notice includes a confirmation which is to be returned.
For further questions call (770) 670-2422.
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
Chair, adjustable, mechanical - Product Code INN
Causa
The aquatec¿ fixed backrest withstands a load of only 250 newtons at uneven load. this may result in the fixed backrest becoming detached from the frame.
Acción
The recall notification will be sent to the two consignees informing them of the recall and to notify their customers. The letter will include a provider letter, customer letter, provider response card and impacted units listing.
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.
A limited number of dv5x series cpap units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on lcd display to appear as "run-test".
Acción
DeVilbiss Healthcare sent an Urgent: Medical Device Correction notice dated May 13, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers.
What to do if you have an affected DV5x Series CPAP unit:
1. Verify your inventory of DV5x Series CPAPs and isolate any units that are on the included serial number list, these units will need to have the serial number corrected.
2. Please contact DeVilbiss Healthcare Customer Service to either request a Sales Representative to correct the issue on site or return the unit back to DeVilbiss to be corrected.
3. If you have already distributed any DV5x Series CPAPs included in this serial number list to end users, a patient communication has been included with this notification - a. Insert your contact information at the bottom of the "User Medical Device Correction Letter" included in this notice.
b. Forward a copy of the "User Medical Device Correction Letter'' to each user to
whom you have provided an affected DV5x Series CPAP unit.
If you have one or more of the affected DV5x Series CPAP unit in your possession (as identified in the serial number list) and have any questions regarding the information provided in this communication, please contact DeVilbiss Healthcare Customer Service at 1-800- 338-1988 from 8:00AM-5:00PM EST. [Note: If you have already spoken with a DeVilbiss Healthcare Representative about this issue, there is no need to call unless you have further questions.]
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
Calculator/data processing module, for clinical use - Product Code JQP
Causa
Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the laboratory information system (lis) that should have been held for manual review.
Acción
An urgent medical device correction notice, dated May 20, 2014, was sent to end users to provide instructions to avoid potential risks associated with the software defect, until changes can be made by a Siemens technical 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.
An update to the virtual simulation software of the syngo rt dosimetrist is necessary to address a safety issue. in special scenarios within the structure operations function the system did not store the selected name from the list of predefined names. after reloading of the data, this structure name had been changed by the system. additionally, a performance issue was addressed where import of di.
Acción
Siemens sent a Medical Device Correction Field Safety Notice of Improvement letter to affected customers via USPS Certified Mail. The letter described the affected product, problem, and actions to be taken.
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
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
There is a misassembly issue with the
photometer installed on dimension¿ integrated chemistry systems instruments. through internal investigation by
siemens healthcare diagnostics has confirmed that a limited number of dimension photometers were misassembled. these photometers are performing within specifications, but may lead to a shortened life of the source lamp.
Acción
An urgent field safety notice, dated May 2014, was sent to users to inform them of the issue and that a service representative would replace the misassembled photometer.
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.
NxStage issued Initial recall letter dated 5/14/14 to dialysis centers. An error was noted and an updated letter dated 5/15/14 was resent to dialysis centers. The updated 5/15/14 letter was emailed to all current active PureFlow SL patients who had provided an email address followed by UPS next business day letter sent to all current active PureFlow SL patients. Accounts are requested to examine inventory and remove product. Contact NxStage Customer Service to arrange for return of all affected product and for
replacement product to be sent. If you have any questions or comments, please feel free to contact NxStage Customer Service at 1-866-NXSTAGE (1-866-697-8243).
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.
Multiple updates to user manuals, instructions for use (ifu), quick reference guides (qrg), and instrument release kits (irk) for use with the da vinci surgical system, instruments and accessories. removal of the emergency grip release wrench, part number 710142.
Acción
Intuitive Surgical sent a Field Safety Notice dated June 16, 2014, to all consignees affected by changes in labeling, IFU User manuals and QRG's. Consignees were instructed to take the following actions:
Ensure all appropriate personnel are fully informed of this Notification. Forward this letter to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff and members of your medical staff who perform da Vinci surgery procedures.
2. Use Attachment C to identify the labeling that has been updated.
3. No manuals or products should be returned. Discard old versions of the User Manuals, IFUs, and QRGs for which you have received updated versions.
4. Discard all versions of the Emergency Grip Release Wrench (Part Number 710142). Order additional IRKs from Intuitive Surgical as needed.
5. Complete and return the attached Acknowledgement Form to acknowledge that you have received the updated Labeling, IRKs, in-service and have discarded all previous versions of Labeling and the emergency grip release wrench. Please return the completed Acknowledgment Form within two days of the in-service.
6. Retain a copy of this Notice and the Acknowledgement Form for your records.
If you need further information or support concerning this recall, please contact your Intuitive Surgical Representative or Intuitive Surgical Customer Service at the numbers listed below:
North America: 800-876-1310 Option 3 (6 am to 5pm PST)
For questions regarding this recall call 408-523-2602.
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.
During an in-process inspection, terumo cardiovascular systems (terumo cvs) identified the presence of
loose fiber particulate that exceeded finished product specifications.
Acción
Terumo sent an Urgent Medical Device Recall letters dated June 27, 2014 to their customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Review this Medical Device Recall notice, 2. Assure that all users in your institution have received notice of this issue and remove any affected units from use, 3. Fill out the Product Tracking Sheet (enclosed), indicating the number of affected units at your institution and fax to 1-877-907-7509 or email to terumo4967@stericycle.com. 4. Complete the Packing Slip (enclosed) and follow the packing instructions to return the affected product, and 5. Terumo CVS will issue credit once the affected units are returned. For questions call Terumo CVS c/o Stericycle 1-866-629-6181.
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.
During an in-process inspection, terumo cardiovascular systems (terumo cvs) identified the presence of
loose fiber particulate that exceeded finished product specifications.
Acción
Terumo sent an Urgent Medical Device Recall letters dated June 27, 2014 to their customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Review this Medical Device Recall notice, 2. Assure that all users in your institution have received notice of this issue and remove any affected units from use, 3. Fill out the Product Tracking Sheet (enclosed), indicating the number of affected units at your institution and fax to 1-877-907-7509 or email to terumo4967@stericycle.com. 4. Complete the Packing Slip (enclosed) and follow the packing instructions to return the affected product, and 5. Terumo CVS will issue credit once the affected units are returned. For questions call Terumo CVS c/o Stericycle 1-866-629-6181.