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
Stimulator - Product Code LGW
Causa
Since april 2004, 27 of 8,769 (0.31%) patients have reported receiving second degree burns in the area of charging and 3 of 8,769 (0.03%) patients have reported receiving third degree burns in the area of charging while using charger 1 .0. some of these events were the direct result of the patient disregarding the instructions for use, such as sleeping with the charger on or placing it directly on.
Acción
In the United States, notification will be sent to patients with the affected devices. Additionally, their physicians on record will be provided with the notification. The Company is currently planning to initiate this field action on September 22, 2008. The U.S. notification will be sent via Fed Ex or U.S. Postal Service certified mail. The letter advises that Boston Scientific Neuromodulation is voluntarily recalling its first generation charging device, Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System. The Charger 1.0 devices are being recalled and will be replaced with the new second generation Precision Charger 2.0 (SC-5312, currently in distribution) that features a temperature limiter for improved temperature management. The Charger 1.0 can be used until replacement with Charger 2.0 by following the instructions on Page 2 of the letter. Customers are asked to complete the acknowledgement form at the end of the letter and return it to Boston Scientific in the return envelope provided. A representative from Boston Scientific will contact them upon receiving the completed form to schedule an in-person visit at their physician's office to exchange the device. Contact Boston Scientific Technical Serives at (866) 566-8913 for assistance.
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
Implanted spinal-cord stimulator for pain relief - Product Code LGW
Causa
Incorrect data -- corruption of internal memory component results in an inability for the physician to reprogram the ipg with firmware version prior to revision 3.02. when this occurs, the ipg will report an error code of "10h0" or "00h0" through the remote control. under this condition, the ipg will cease to log in some data that could be used for informational purposes. ** it should be noted t.
Acción
Advanced Bionics sent an Important Notification letter on October 5, 2007, via FED-Ex or US Postal Service Certified mail. (International notification activity is in progress.) The recall letter advises that the firm has become aware of an issue with Precision Implantable Pulse Generators (IPG model numbers SC-1100, Sc1110, and ONS-1110) manufactured prior to July 2007. The letter describes the issue in detail. The firm is requesting that customer immediately locate the affected IPGs and set them aside so that they are not used. A Boston Scientific/Advanced Bionics sales representative will contact your facility to confirm these IPGs and arrange for the exchange of these devices.
The firm enclosed Reply Verification Tracking Form listing the IPGs that are at your Clinic according to the firm's records. In addition, the firm recommends that if error code 10h0 or 00h0 is encountered in Implanted IPGs, it may be corrected by upgrading to a newer version of IPG firmware (software that runs in the IPG). The new version of firmware corrects this condition and helps prevent it from occurring in the future. This firmware upgrade is performed non-invasively, through wireless RF telemetry.
If any of patients encounter error code "10h0" or "00h0" on their Remote Control, consignees are advised to contact their Advanced Bionics representative or Technical Services team at (866) 566-8913 to help identify whether the condition can be corrected through a firmware upgrade and, if so, they will help arrange for the upgrade. Please note that some devices may not be upgradeable. The firm request that all consignees return the notification acknowledgement form is included with the letter.
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
Autonomic Nerve Stimulator - Product Code LYJ
Causa
Screen freezes-- the dell x5 handheld pc screen will freeze caused due to incompatibility between the microsoft 2002 os and the model dell x5 handheld computer. once frozen, the handheld device becomes non-responsive to user input.
Acción
Cyberonics sent an initial notification (Important Safety Alert) to physicians via Certified Mail on 10/01/07. Letter notified physicians that the Dell X5 handheld computer screen will freeze following an interrogation. Once frozen the handheld device becomes non-responsive to user inputs. The firm informed the user that in the event that the computer becomes non-responsive, the user has two options, 1) Reinitialized the flash memory and, 2) Perform a software reset of the handheld computer. A second notification addressing the approval and addition of labeling was sent to physicians on 11/15/07. Physicians were asked to respond to both letters via an enclosed response card, acknowledging receipt of the notification. Additional information will be posted at www.VNStherapy.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
ventilation accessories - Product Code GWO
Causa
Foreign material: glass fragments may present in the plastic bag material used to ship components.
Acción
The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent.
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
ventilation accessories - Product Code GWQ
Causa
Foreign material: glass fragments may present in the plastic bag material used to ship components.
Acción
The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent.
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
Stereotaxic instrument - Product Code HAW
Causa
Sterilty (package integrity) compromised: some failures were for damage to the outer pouch, while another set of failures were for the seals on this pouch. the seal between the inner tray and lid has not been compromised and the contents remain sterile, however, the sterility of the outer surfaces of the inner tray and lid cannot be assured.
Acción
On 10/4/2007, consignees were notified by Medtronic field personnel, either by personal visits or telephone.
All wholesalers of this product are OUS. Medtronic OUS Regulatory personnel communicated this issue directly to the wholesalers, who provided the letters to their customers. Medtronic field personnel are responsible for completing and returning reply cards confirming all notifications (100%).
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
Implanted spinal-cord stimulator for pain relief - Product Code LGW
Causa
Incorrect data -- corruption of internal memory component results in an inability for the physician to reprogram the ipg with firmware version prior to revision 3.02. when this occurs, the ipg will report an error code of "10h0" or "00h0" through the remote control. under this condition, the ipg will cease to log in some data that could be used for informational purposes. ** it should be noted t.
Acción
Advanced Bionics sent an Important Notification letter on October 5, 2007, via FED-Ex or US Postal Service Certified mail. (International notification activity is in progress.) The recall letter advises that the firm has become aware of an issue with Precision Implantable Pulse Generators (IPG model numbers SC-1100, Sc1110, and ONS-1110) manufactured prior to July 2007. The letter describes the issue in detail. The firm is requesting that customer immediately locate the affected IPGs and set them aside so that they are not used. A Boston Scientific/Advanced Bionics sales representative will contact your facility to confirm these IPGs and arrange for the exchange of these devices.
The firm enclosed Reply Verification Tracking Form listing the IPGs that are at your Clinic according to the firm's records. In addition, the firm recommends that if error code 10h0 or 00h0 is encountered in Implanted IPGs, it may be corrected by upgrading to a newer version of IPG firmware (software that runs in the IPG). The new version of firmware corrects this condition and helps prevent it from occurring in the future. This firmware upgrade is performed non-invasively, through wireless RF telemetry.
If any of patients encounter error code "10h0" or "00h0" on their Remote Control, consignees are advised to contact their Advanced Bionics representative or Technical Services team at (866) 566-8913 to help identify whether the condition can be corrected through a firmware upgrade and, if so, they will help arrange for the upgrade. Please note that some devices may not be upgradeable. The firm request that all consignees return the notification acknowledgement form is included with the letter.
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.
No fda clearance for the .35hz/.45hz frequency option on device.
Acción
Consignees were notified of this recall by an Urgent Device Recall Letter sent via U.S. First Class mail on 10/29/07. The letter instructs users to contact the recalling firm to make arrangements to return the device. The letter also instructs users to return an enclosed response card. Consignees who do not respond will receive a follow-up telephone call two weeks after initial mailing of recall notice. For more information, contact firm at 1-866-937-4237.
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
Electroencephalograph - Product Code GWQ
Causa
Display lock-up: viasys healthcare nicoletone icu monitor freezes up during operation when using the digital video option.
Acción
Certified direct mail delivery of URGENT MEDICAL DEVICE FIELD CORRECTION (RECALL) were made to consignees on 9/11/07 by Nicolet Biomedical Div of Viasys Healthcare. The letter describes the product and problem. VIASYS requests that customers cease use of the video option of the device until the monitor can be replaced by VIASYS authorized personnel. Letter also requests consignees to fax or mail back the response form.
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
VNS handheld PCs - Product Code LYJ
Causa
During programming, pulse generator may be inadvertently set to 8.0 ma output, regardless of the ma range selected by the clinician.
Acción
Firm sent safety alert to physicians on 11/14/06. Safety Alert informs physicians of the problem and provides instructions on how to avoid an event and correct an event should it occur.
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
VNS System Flashcards (software) - Product Code LYJ
Causa
During programming, pulse generator may be inadvertently set to 8.0 ma output, regardless of the ma range selected by the clinician.
Acción
Firm sent safety alert to physicians on 11/14/06. Safety Alert informs physicians of the problem and provides instructions on how to avoid an event and correct an event should it occur.
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
spinal cord stimulation leads - Product Code LGW
Causa
A small number of unimplanted precision linear leads may have been assembled with incorrect electrode material. at high stimulation levels, the metal may corrode and dissolved metals may enter the patient.
Acción
In United States, the clinician recall notification letters were distributed by Fed-Ex or U.S. Postal Service certified mail on 09/21/2006. For the other regions, the in-country representatives started providing notification to the clinicians on 09/21/2006.
The recall notification letters will instruct physicians to immediately return the unimplanted units.
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
Navigation System - Product Code HAW
Causa
A component of the device is a dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.
Acción
A recall letter dated 9/8/06 was sent to each customer instructing them to remove the battery from their Dell laptop computer model D800, to check the batteries to determine whether they are affected by the recall, and to only use the computer on AC power until they have requested and received replacement batteries.
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
Navigation System - Product Code HAW
Causa
A component of the device is a dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.
Acción
A recall letter dated 9/8/06 was sent to each customer instructing them to remove the battery from their Dell laptop computer model D800, to check the batteries to determine whether they are affected by the recall, and to only use the computer on AC power until they have requested and received replacement batteries.
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
Navigation System - Product Code HAW
Causa
A component of the device is a dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.
Acción
A recall letter dated 9/8/06 was sent to each customer instructing them to remove the battery from their Dell laptop computer model D800, to check the batteries to determine whether they are affected by the recall, and to only use the computer on AC power until they have requested and received replacement batteries.
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
Navigation system - Product Code HAW
Causa
A component of the device is a dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.
Acción
A recall letter dated 9/8/06 was sent to each customer instructing them to remove the battery from their Dell laptop computer model D800, to check the batteries to determine whether they are affected by the recall, and to only use the computer on AC power until they have requested and received replacement batteries.
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.
Power assist microtargeting system may advance beyond intended target.
Acción
FHC Inc. and Medtronic notified customers by letter and instructs the customer to return their Motor Option for upgrade to include the following components:
1) Handheld Remote Control, 2) Motor Controller Unit with Display, 3) Motor, and 4)
Medical Power Adapter. (See pictures at the end of this communication). Until the Motor Option has been updated, instructions to customers are:
Prior to each clinical use:
¿ Ensure the microTargeting Drive system is calibrated before each clinical use per the User Guide.
¿ Check the microTargeting Drive system functionality over a range of at least 10mm movement.
¿ Should any performance indicating either a stall or unintended movement be observed, immediately unplug the 12V Medical Power Adapter, remove the
MicroTargeting Drive Motor Option from the system, and continue using the microTargeting Drive in the manual mode.
During clinical use:
¿ Should any performance indicating either a stall or unintended movement be observed, immediately unplug the 12V Medical Power Adapter, remove the
MicroTargeting Drive Motor Option from the system, and continue using the microTargeting Drive in the manual mode.
Every 100 uses or annually:
¿ Have your microTargeting Drive system checked by the manufacturer per the User Guide.
¿ Have your equipment support department check or tighten the MicroTargeting Drive Motor Option Remote Control Knob set screws, tighten as needed, and then re-calibrate.
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.
Power assist microtargeting system may advance beyond intended target.
Acción
FHC Inc. and Medtronic notified customers by letter and instructs the customer to return their Motor Option for upgrade to include the following components:
1) Handheld Remote Control, 2) Motor Controller Unit with Display, 3) Motor, and 4)
Medical Power Adapter. (See pictures at the end of this communication). Until the Motor Option has been updated, instructions to customers are:
Prior to each clinical use:
¿ Ensure the microTargeting Drive system is calibrated before each clinical use per the User Guide.
¿ Check the microTargeting Drive system functionality over a range of at least 10mm movement.
¿ Should any performance indicating either a stall or unintended movement be observed, immediately unplug the 12V Medical Power Adapter, remove the
MicroTargeting Drive Motor Option from the system, and continue using the microTargeting Drive in the manual mode.
During clinical use:
¿ Should any performance indicating either a stall or unintended movement be observed, immediately unplug the 12V Medical Power Adapter, remove the
MicroTargeting Drive Motor Option from the system, and continue using the microTargeting Drive in the manual mode.
Every 100 uses or annually:
¿ Have your microTargeting Drive system checked by the manufacturer per the User Guide.
¿ Have your equipment support department check or tighten the MicroTargeting Drive Motor Option Remote Control Knob set screws, tighten as needed, and then re-calibrate.
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.
Certain model ns-p probes contained in the neurosensor cerebral blood flow and intracranial pressure monitoring kit may allow an intracranial pressure (icp) drift of up to ¿ 5 mmhg during the first 24 hours of monitoring icp. this is outside the products labeling specification of ¿ 2 mmhg maximum icp drift within the first 24 hours of monitoring.
Acción
Notify Customers and Sales Representatives who received the product by letter sent via Federal Express. Customers will be instructed that an Integra Sales Representative will contact them to arrange for return of affected product.
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.
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.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Endoscope, Neurological - Product Code GWG
Causa
Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa.
Acción
Firm sales representatives will contact customers and hand deliver the recall notice.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Endoscope, Neurological - Product Code GWG
Causa
Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa.
Acción
Firm sales representatives will contact customers and hand deliver the recall notice.
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.
Stryker instruments and stryker leibinger gmbh & co. kg are
voluntarily recalling certain serial numbers thoracic pedicle feelers that are used in conjunction with the stryker¿ navigation
system because the settings on
the machine were higher than intended. this change led to increased energy directed onto the tip of the thoracic pedicle
feeler which caused material degradation where the laser marks exist. there is the potential for the tip of the thoracic pedicle feeler to break.
Acción
US customers will be notified via FedEx overnight. US Sales Representatives will be notified via email. International entities will be notified via an internal notification system. International customers will be notified per local regulations/procedures.
Customer Instructions:
Actions to be taken by the Customer/User:
1. Immediately review this Recall Notification.
2. Immediately check all stock areas and/or operating room storage for affected equipment. Quarantine and
discontinue use of any affected Thoracic Pedicle Feelers.
3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this Notification and identify how many
affected items are currently in your inventory. Please complete and return the BRF even if you don't have any affected product on hand.
Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the
instructions in the Notification.
4. If you have further distributed this product, please forward this Notification and the attached BRF to all affected locations. Please indicate each location on the BRF.
5. If the BRF for your facility indicates that recalled product is currently on hand, we will contact you to arrange for the return of the product for repair/replacement.
If discontinuing use of the specific Thoracic Pedicle Feeler(s) listed will cause disruption at your facility. For further questions, please call (269) 323-7700.
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
Motor, drill, pneumatic - Product Code HBB
Causa
The elan 4 air system was released to the market place prior to an authorized fda 510k clearance. this issue does not affected sales outside the united states (ous).
Acción
On September 1, 2017 an Urgent Medical Device Recall letter was issued to customers for the ELAN 4 Air System which includes the following sub-components:
ST0607 ELAN 4 Air Control Set
ST0608 ELAN 4 Air Neuro Crani Set
ST0609 ELAN 4 Air Spine Set
ST06411 ELAN 4 Air HD Spine Set
ST0614 ELAN 4 Air Micro Saw Set
ST0615 ELAN 4 Air Hand Control Set
ST0638 ELAN 4 Air Large Saw Set
The letter directs customers to take the following actions:
1. Review the Voluntary Urgent Medical Device Recall Notification Letter in its entirety and ensure that all users in your organization and other concerned persons are informed about this recall and immediately discontinue use.
2. Determine your current inventory of affected products within your facility. Immediately remove the affected products and return to Aesculap Inc. Do not destroy any affected products.
3. Utilizing the attached Product Recall Acknowledgement Response Form on the next page of this letter, record the total number of products in your possession. If you have no inventory remaining, please enter zero (0) on the form and a REASON WHY (example, returned evaluation system to sales representative).
4. Please contact Customer Service and they will provide you with a Returned Goods number and return label.
Customer Service: 1-800-282-9000
aesculap_emailorders.bbmus_service@bbraun.com