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.
Sensor cables may suffer material degradation when exposed to certain sterilization procedures.
Acción
GE OEC Medical Systems, Inc sent an Urgent Recall Notice dated March 1, 2011, by certified letter on February 24, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised if their Transmitter Sensor Cables or Receiver Sensor Cables have been exposed to any STERRAD sterilizer other than STERRAD 1005, discontinue use of these sterilizers for this product.
The Transmitter Sensor Cables should be inspected for signs of material degradation.
Further information is available at 800-874-7378.
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.
Sensor cables may suffer material degradation when exposed to certain sterilization procedures.
Acción
GE OEC Medical Systems, Inc sent an Urgent Recall Notice dated March 1, 2011, by certified letter on February 24, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised if their Transmitter Sensor Cables or Receiver Sensor Cables have been exposed to any STERRAD sterilizer other than STERRAD 1005, discontinue use of these sterilizers for this product.
The Transmitter Sensor Cables should be inspected for signs of material degradation.
Further information is available at 800-874-7378.
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
Compressor, cardiac, external - Product Code DRM
Causa
Complaints of batteries discharging prematurely and that during use the auto pulse units would cease operating (providing compressions).
Acción
The firm, Zoll Circulation Inc., initiated a Corrective and Preventive Action Report on January 28, 2009. According to the firm, the customers were contacted by telephone calls and were provided with a Battery Maintenance program. For further questions you may call (408) 541-2140 ext.341.
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 recall was initiated because biosense webster has confirmed that there is an inaccessibility of electronic version of the instruction for use (e-ifu) for the "10 ft. interface cable, 10 pin-shielded tip pins to 12 pin-blue", catalog number d128709, through the j&j; gateway (ie, e-ifu website).
Acción
Biosense Webster, Inc. sent an Urgent Field Safety Notice letter dated March 16, 2011, to all affected customers (via express mail). The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the enclosed Acknowledgement Form to confirm that all customers who received the product have been notified accordingly of this concern. If customers have any questions or require additional information, they are to contact their BWI representative and return the Acknowledgement form to:
Biosense Webster, Inc.
l5715 Arrow Highway
Irwindale, CA 91706
Attn: Recall Coordinator - Virgil Ellsworth
Phone: (909) 839-8500
Fax Number: (909) 839-7207.
For questions regarding this recall call 909-839-7207.
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
dental chair - Product Code NRU
Causa
The link arm assembly that connects some rear mounted options to the spirit 3000 or spirit 1800 dental chairs may potentially break and fall off the dental chair.
Acción
Pelton & Crane sent an "Urgent Medical Device Recall" letter dated 3/04/2011. They were instructed to: Locate the affected devices this recall is in regards to. Schedule service with the end user for Pelton & Crane representative to replace the affected components this recall is in regards to. International accounts were instructed to order link arm assemblies from Pelton & Crane and replace the affected components. All consignees were to complete the Recall Acknowledgement/Return Form and return the form to Pelton & Crane.
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 firm has received two reports of the terumo weighted flexible sucker becoming ensnared in cardiac tissue after it was inserted into a ventricle through a valve. the firm has determined that the products's instructions for use are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. however this is not stated in the ifu. the firm is conducting.
Acción
SEE UPDATE BELOW IN ALL CAPS.
The firm, Terumo Cardiovascular Systems (Terumo CVS), sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were informed that the product's Indications For Use (IFU) are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. However, this is not stated in the IFU. In addition, the customers were instructed to read and understand the changes and clarifications to the product's IFU; review the Medical Device Correction notice; assure that all users are aware of this notice, and confirm receipt of this communication by faxing the attached Customer Response Form via fax to: Terumo CVS Customer Service at 800-292-6551 (US only).
If you have any questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818. Customers Service hours: Monday-Friday, 8AM-6PM.
ON 8/30/2011 THE FIRM ISSUE A LETTER ENTITLED "URGENT MEDICAL DEVICE RECALL" THAT STATED "AFTER FURTHER CONSIDERATION, TERUMO CVS DECIDED TO DISCONTINUE SALES OF THE WEIGHTED FLEXIBLE SUCKER AND IS ASKING USERS TO RETURN ALL UNUSED PRODUCT" TO THE FIRM.
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
dental chair - Product Code NRU
Causa
The link arm assembly that connects some rear mounted options to the spirit 3000 or spirit 1800 dental chairs may potentially break and fall off the dental chair.
Acción
Pelton & Crane sent an "Urgent Medical Device Recall" letter dated 3/04/2011. They were instructed to: Locate the affected devices this recall is in regards to. Schedule service with the end user for Pelton & Crane representative to replace the affected components this recall is in regards to. International accounts were instructed to order link arm assemblies from Pelton & Crane and replace the affected components. All consignees were to complete the Recall Acknowledgement/Return Form and return the form to Pelton & Crane.
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 arm adapter does not contain labelling specifying the applicable weight and moment limitations of the arm adapter.
Acción
Steris Corporation sent an Urgent Field Correction Notice letter dated February 18, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A Steris representative would contact customers to arrange for replacement of the product. For questions regarding the firms visit to their facility, customers were instructed to contact Steris Field Service Dispatch at 1-800-333-8828.
For any questions regarding this matter call 440-392-7705.
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 and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
Notas adicionales en la data
Knife, Opthalmic - Product Code H--NN
Causa
Loose blades in the handle of knives due to uncured epoxy.
Acción
Beaver Visitec International, Inc.sent an Urgent Recall Notification letter dated February 25, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all unused product and to complete a Customer Response Form (to be returned via fax to 866-906-4304.
For questions regarding this recall call 781-906-7917.
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
During product monitoring, firm discovered a possible hazard to patients when using the detector alpha rotation of all axiom aristos fx and fx plus systems with serial numbers up to and including 1216. when using the detector alpha rotation, the detector may descend unexpectedly during movement or in vertical or table mode. if this occurs in vertical modes, the possibility exists that the detect.
Acción
The firm, SIEMENS, sent a "Safety Advisory Notice" dated February 15, 2011 to the affected customers via Update Instructions XP016/10/S on February 17, 2011. The notice described the product, problem and actions to be taken. The customers were instructed to immediately instruct their personnel accordingly; ensure that the safety advisory is placed in the systems's instructions for use; if they have sold this device/equipment and it is no longer in their possession, forward this safety notice to the new owner of the device/equipment; inform SIEMENS about the new owner of the device/equipment, and complete and return the Acknowledgement of receipt form. SIEMENS is preparing a modification of AXIOM Aristos FX and FX Plus that will resolve this potential malfunction. The field modification will be available from February 2011 and is expected to be carried out May 31, 2011.
If you have any questions, call 09131-18-9908 or +1-888-826-9702.
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
An anomaly was identified in the aria version 8.0 and 8.1, when an image sequence template is added to a field in rt chart and a ciao (completely irradiated aperture opening) is calculated, the resulting ciao display at 4ditc may be incorrect.
Acción
Varian Medical Systems sent an Urgent Medical Device Correction letter dated February 18, 2011, to all affected customers via Federal Express.. The letter identified the product, the problem, and the action to be taken by the customer. Varian has made design changes to address the issue in ARIA Radiation Oncology versions 8.2 and later. A corrective action will be undertaken to upgrade all affected items.
For questions regarding this recall call US and Canada 1-888-VARIAN5 (888-827-4265.
Europe +41 41 749 8844
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
Needle, Hypodermic, Single Lumen - Product Code FMI
Causa
Needle cannula may separate from the hub during use.
Acción
Recall letters requesting product return were mailed to all customers on October 8, 2004
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
dental chair - Product Code NRU
Causa
Link arm assembly that mounts the rear mounted accessories to the dental chair may potentially break and fall off the dental chair.
Acción
On 03/08/11, Dental Equipment LLC. started sending out the Medical Device Recall notification letter via USPS 1st class mail to US consignees and Federal Express mail to foreign consignees.
The firm also sent a recall notification letter to consignees who only purchased dental accessories such as Rear Mounted Cuspidor with Coverset, Arm Articulating Rear Mounted Cuspidor - Marus Gray, Maxstar Orbit Cuspidor utility W/ Porcelain bowl, and zinc plated bolts.
The letter identified the affected dental chair as Marus brand with the following model numbers: DC1490, DC1690, DC1700 and DC1702.
The firm's corrective action including the replacement of the affected link arm assembly with a new link arm assembly. The firm's field representative will contact each consignee for an appointment to replace the affected link arm assembly.
Consignees can contact the Dental Equipment LLC at 503-537-3617 for any 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.
Possibility of epoxy debris particles inside the catheter lumen.
Acción
The firm, Millar, notified their consignees/customers by email and sent hardcopy of email on March 8, 2011. The notification described the product, problem and actions to be taken. The customers were instructed to return the catheter(s) to Millar or report back to Millar if the catheter(s) has been consumed.
If you have any questions, please do not hesitate to contact Director, RA/QA at 832-667-7000.
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 firm has received two reports of the terumo weighted flexible sucker becoming ensnared in cardiac tissue after it was inserted into a ventricle through a valve. the firm has determined that the products's instructions for use are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. however this is not stated in the ifu. the firm is conducting.
Acción
SEE UPDATE BELOW IN ALL CAPS.
The firm, Terumo Cardiovascular Systems (Terumo CVS), sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were informed that the product's Indications For Use (IFU) are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. However, this is not stated in the IFU. In addition, the customers were instructed to read and understand the changes and clarifications to the product's IFU; review the Medical Device Correction notice; assure that all users are aware of this notice, and confirm receipt of this communication by faxing the attached Customer Response Form via fax to: Terumo CVS Customer Service at 800-292-6551 (US only).
If you have any questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818. Customers Service hours: Monday-Friday, 8AM-6PM.
ON 8/30/2011 THE FIRM ISSUE A LETTER ENTITLED "URGENT MEDICAL DEVICE RECALL" THAT STATED "AFTER FURTHER CONSIDERATION, TERUMO CVS DECIDED TO DISCONTINUE SALES OF THE WEIGHTED FLEXIBLE SUCKER AND IS ASKING USERS TO RETURN ALL UNUSED PRODUCT" TO THE FIRM.
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
Image-Intensified Fluoroscopic X-Ray System - Product Code JAA
Causa
Under some conditions during high doses procedures the cumulative air kerma display may reach its maximum capability and fail to display the accrued value.
Acción
An Important: Electronic Product Radiation Warning notification was sent to all consignees. The letters described the reason for the recall and identified the affected product. The system software will be modified to allow the shift of the decimal to one position to the right allowing for a display of 99999.9 mGy. This will allow for the retention of the resolution until such time as the system exceeds the 9999.99 mGy range. A Toshiba Service person will contact customers when the software is available. Installed systems with the current version of software ( version 4.23) will begin to receive the corrected software April 2011. Previous versions of the software will begin to receive corrected software June 2011. The software will be provided free of charge. Questions related to the letter should be directed to the Regulatory Affairs Department at 800-421-1968.
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
Image-Intensified Fluoroscopic X-Ray System - Product Code JAA
Causa
Under some conditions during high doses procedures the cumulative air kerma display may reach its maximum capability and fail to display the accrued value.
Acción
An Important: Electronic Product Radiation Warning notification was sent to all consignees. The letters described the reason for the recall and identified the affected product. The system software will be modified to allow the shift of the decimal to one position to the right allowing for a display of 99999.9 mGy. This will allow for the retention of the resolution until such time as the system exceeds the 9999.99 mGy range. A Toshiba Service person will contact customers when the software is available. Installed systems with the current version of software ( version 4.23) will begin to receive the corrected software April 2011. Previous versions of the software will begin to receive corrected software June 2011. The software will be provided free of charge. Questions related to the letter should be directed to the Regulatory Affairs Department at 800-421-1968.
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
Image-Intensified Fluoroscopic X-Ray System - Product Code JAA
Causa
Under some conditions during high doses procedures the cumulative air kerma display may reach its maximum capability and fail to display the accrued value.
Acción
An Important: Electronic Product Radiation Warning notification was sent to all consignees. The letters described the reason for the recall and identified the affected product. The system software will be modified to allow the shift of the decimal to one position to the right allowing for a display of 99999.9 mGy. This will allow for the retention of the resolution until such time as the system exceeds the 9999.99 mGy range. A Toshiba Service person will contact customers when the software is available. Installed systems with the current version of software ( version 4.23) will begin to receive the corrected software April 2011. Previous versions of the software will begin to receive corrected software June 2011. The software will be provided free of charge. Questions related to the letter should be directed to the Regulatory Affairs Department at 800-421-1968.
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
Image-Intensified Fluoroscopic X-Ray System - Product Code JAA
Causa
Under some conditions during high doses procedures the cumulative air kerma display may reach its maximum capability and fail to display the accrued value.
Acción
An Important: Electronic Product Radiation Warning notification was sent to all consignees. The letters described the reason for the recall and identified the affected product. The system software will be modified to allow the shift of the decimal to one position to the right allowing for a display of 99999.9 mGy. This will allow for the retention of the resolution until such time as the system exceeds the 9999.99 mGy range. A Toshiba Service person will contact customers when the software is available. Installed systems with the current version of software ( version 4.23) will begin to receive the corrected software April 2011. Previous versions of the software will begin to receive corrected software June 2011. The software will be provided free of charge. Questions related to the letter should be directed to the Regulatory Affairs Department at 800-421-1968.
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
Dressing, wound and burn, occlusive - Product Code MGP
Causa
Misbranded; the expiry date on the primary packing incorrectly indicates 2010-10, instead of 2015-10. consignees were notified by letter on/about 02/11/2011. they were advised to examine their inventory and not to use any of the affected product and to return it to paul hartmann. a response form was included to be completed and returned to paul hartmann. they were further instructed to pass the no.
Acción
Hartmann USA, Inc. sent letter to the Consignees on 2/11/11. They were advised to examine their inventory and not to use any of the affected product and to return it to Hartmann USA, Inc. A response form was included to be completed and returned to Hartmann USA, Inc. They were further instructed to pass the notice on to their consignees if distributed. For questions, call
(803) 325-7600.
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.
The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval.
Acción
Given Imaging, Inc. consignees were notified via FedEx letter on/about 03/08/2011. They instructed to return all affected product. A Customer Response form with return instructions was included to be completed and returned to Given Imaging.
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
burn and wound dressing - Product Code MGR
Causa
Product sterility may be compromised.
Acción
Organogenesis contacted the accounts by telephone and fax on 2/24/11 to advise of the contamination and identification fo the organism for appropriate patient follow-up.
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 firm has received two reports of the terumo weighted flexible sucker becoming ensnared in cardiac tissue after it was inserted into a ventricle through a valve. the firm has determined that the products's instructions for use are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. however this is not stated in the ifu. the firm is conducting.
Acción
SEE UPDATE BELOW IN ALL CAPS.
The firm, Terumo Cardiovascular Systems (Terumo CVS), sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were informed that the product's Indications For Use (IFU) are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. However, this is not stated in the IFU. In addition, the customers were instructed to read and understand the changes and clarifications to the product's IFU; review the Medical Device Correction notice; assure that all users are aware of this notice, and confirm receipt of this communication by faxing the attached Customer Response Form via fax to: Terumo CVS Customer Service at 800-292-6551 (US only).
If you have any questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818. Customers Service hours: Monday-Friday, 8AM-6PM.
ON 8/30/2011 THE FIRM ISSUE A LETTER ENTITLED "URGENT MEDICAL DEVICE RECALL" THAT STATED "AFTER FURTHER CONSIDERATION, TERUMO CVS DECIDED TO DISCONTINUE SALES OF THE WEIGHTED FLEXIBLE SUCKER AND IS ASKING USERS TO RETURN ALL UNUSED PRODUCT" TO THE FIRM.
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
Arthroscope - Product Code HRX
Causa
Insufficient cleaning instruction were included for the inflow/outflow cannula in the user manual.
Acción
The firm, Stryker, issued an "URGENT: DEVICE CORRECTION" memo dated March 8, 2011 to all customers. The memo described the product, problem and actions to be taken. The customers were instructed to discard any old Instructions for Use (1000-400-816 rev. A or B) for their Inflow/Outflow Cannual; download the new IFU (1000-400-816 rev. C) from the URL link: http://stryker.com/InflowOutflowCannual; ensure they follow the new cleaning instructions provided in the IFU and complete and return the enclosed "acknowledgement of receipt" form and fax to (408) 754-8378 or scan in and email to cannula@stryker.com. Stryker stated in the memo that "It is important to send the self addressed confirmation forms back to Stryker RAQA".
If you have any questions regarding this letter, please contact us by phone at 1-800-624-4422 or via email at cannula@stryker.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
Intracranial neurovascular stent - Product Code NJE
Causa
Mislabeled: one of the stick on stickers on the sterile pouch inside of the product box indicates the stent size to be 22mm in length, when in fact the product is 28mm in length.
Acción
Codman & Shurtleff, Inc.sent an "Urgent Medical Device Correction Notice" on March 21, 2011.
The letter recommend the incorrect label be removed and discarded. There are 3 additional peel-off labels, 2 on the outer box and one on the pouch. All 3 of these contain the correct printed size information (28 mm) that can be used for applying to the inventory sheet, patient record or patient card, as needed.
It is NOT required to return any of this product to Codman.
Customer Service at 1-800-225-0460 or contact your local Codman Neurovascular Representative