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
Gauze/sponge, internal, x-ray detectable - Product Code GDY
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.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
Gauze/sponge, internal, x-ray detectable - Product Code GDY
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.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
Gauze/sponge, internal, x-ray detectable - Product Code GDY
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.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
Gauze/sponge, internal, x-ray detectable - Product Code GDY
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.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
Screw, fixation, bone - Product Code HWC
Causa
A small hole may be present in the inner tray of specific lots of sterile hip and trauma implant screws.
Acción
All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
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
Gauze/sponge, internal, x-ray detectable - Product Code GDY
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.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.
Lumenis ltd announces a field action of the m22 ipl acne filters for the lumenis m22 ipl hand piece due to the risk of superficial burns when using the device.
Acción
Customers were notified on November 17, 2015 by Customer Notification Letter and customers were asked to return the device.
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
Gauze/sponge, internal, x-ray detectable - Product Code GDY
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.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
Gauze/sponge, internal, x-ray detectable - Product Code GDY
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.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
Gauze/sponge, internal, x-ray detectable - Product Code GDY
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.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
Gauze/sponge, internal, x-ray detectable - Product Code GDY
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.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
Gauze/sponge, internal, x-ray detectable - Product Code GDY
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.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
Gauze/sponge, internal, x-ray detectable - Product Code GDY
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.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
Gauze/sponge, internal, x-ray detectable - Product Code GDY
American Surgical issued an Urgent Recall and Field Safety Notice letter
dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B:
Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed.
Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC.
Complete and return confirmation of actions described in Field Safety Notice.
Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460
Email: CustomerService@AmericanSurgical.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
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
A small hole may be present in the inner tray of specific lots of sterile hip and trauma implant screws.
Acción
All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
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 autospect pro application was only designed to reconstruct cardiac spect data obtained with detectors positioned at 90¿ or 180¿ relative to one another. however, certain gamma cameras allow for other relative detector angles. data acquired at these other angles will not be correctly reconstructed by autospect pro and the results will likely be erroneous.
Acción
On March 4, 2016, the firm sent an URGENT - Field Safety Notice Medical Device Correction letter to their customers. The letter identified the affected device, the reason for the recall, and under what circumstances the problem occurs. Customers are to contact Philips as described if they are unsure whether their gamma cameras supports the modes. The firm will implement the AutoSPECT Pro software upgrade and contact customers to schedule the appointment. If further assistance or support is needed, customers are to contact their local Philips 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.
The autospect pro application was only designed to reconstruct cardiac spect data obtained with detectors positioned at 90¿ or 180¿ relative to one another. however, certain gamma cameras allow for other relative detector angles. data acquired at these other angles will not be correctly reconstructed by autospect pro and the results will likely be erroneous.
Acción
On March 4, 2016, the firm sent an URGENT - Field Safety Notice Medical Device Correction letter to their customers. The letter identified the affected device, the reason for the recall, and under what circumstances the problem occurs. Customers are to contact Philips as described if they are unsure whether their gamma cameras supports the modes. The firm will implement the AutoSPECT Pro software upgrade and contact customers to schedule the appointment. If further assistance or support is needed, customers are to contact their local Philips 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
System, x-ray, tomography, computed - Product Code JAK
Causa
The autospect pro application was only designed to reconstruct cardiac spect data obtained with detectors positioned at 90¿ or 180¿ relative to one another. however, certain gamma cameras allow for other relative detector angles. data acquired at these other angles will not be correctly reconstructed by autospect pro and the results will likely be erroneous.
Acción
On March 4, 2016, the firm sent an URGENT - Field Safety Notice Medical Device Correction letter to their customers. The letter identified the affected device, the reason for the recall, and under what circumstances the problem occurs. Customers are to contact Philips as described if they are unsure whether their gamma cameras supports the modes. The firm will implement the AutoSPECT Pro software upgrade and contact customers to schedule the appointment. If further assistance or support is needed, customers are to contact their local Philips 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.
Incorrect power supply in the package, rendering the device inoperable.
Acción
Customers were notified on March 30, 2016 via telephone call. LED Technologies, Inc. provided the consignee with a letter to distribute to customers who purchased the reVive Light Therapy Pain Relief device, and included instructions to receive a replacement of the correct power supply.
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 recent firmware update developed by medtronic for the 2490c carelink monitors and 2020b carelink express monitors included incorrect data on the country analog modem dial-up configuration table used to dial into the carelink network. this incorrect data resulted in the removal of the 0 prefix necessary for select countries as well as an incorrect alignment of phone numbers for other select cou.
Acción
Medtronic sent an "Urgent Field Safety Notice" dated April 2016to their customers. The letter was addressed to Healthcare Professional. The letter identified the affected product, problem and customer actions to be taken. For questions contact your local Medtronic 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
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
The firm identified an issue in sample processing when using ezee-nest insert cups due to two inaccuracies that exist in the advia centaur cp operators guide.
Acción
Siemens sent an Urgent Medical Device Correction letter dated March 2016, to all affected customers. The letter was sent to the US customers via Fed Ex beginning on March 30, 2016., and were e-mailed dated March 20, 2016, to regional countries for implementation outside the US. Field service personnel were sent a support bulletin describing the issue and instructing them how to manage customer questions.
" Complete and return the Field Correction Effectiveness Check form attached to this letter within 30 days.
" Please review this letter with your Medical Director.
Please retain this letter with your laboratory records, and forward this letter to those who may have received this product.
We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions, please call (914) 524-2868.
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.
Maquet cardiopulmonary, the manufacturer of the rotaflow centrifugal pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. angiodynamics confirmed that the affected rotaflow centrifugal pumps were included in packaged angiovac circuit packs.
Acción
On 3/21/2016, AngioDynamics sent recall notification packages (dated 3/21/2016) to the consignees via Federal Express. Consignees are instructed to follow the instructions provided on the Maquet Cardiopulmonary recall letter (dated 2/23/2016) and return the Reply Verification Tracking Form, provided in the recall notification.
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.
Maquet cardiopulmonary, the manufacturer of the rotaflow centrifugal pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. angiodynamics confirmed that the affected rotaflow centrifugal pumps were included in packaged angiovac circuit packs.
Acción
On 3/21/2016, AngioDynamics sent recall notification packages (dated 3/21/2016) to the consignees via Federal Express. Consignees are instructed to follow the instructions provided on the Maquet Cardiopulmonary recall letter (dated 2/23/2016) and return the Reply Verification Tracking Form, provided in the recall notification.
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
Ventilator, continuous, facility use - Product Code CBK
Causa
After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected.
Acción
Hamilton Medical Inc. sent an" Medical Device Field Safety Corrective Action" letter dated March 7, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Hamilton Medical then had to compile a list of to whom they had distributed the affected ventilators and sent letters on April 6, 2016. Letters included the Medical Device Field Safety Corrective Action from Hamilton AG. Letters included immediate actions to be take by use and that reps will be visiting each site to upgrade ventilators to v 2.60 to alleviate the issue.
Distributors will update software and will provide an updated Operator's manual as soon as it is available.
Questions may be directed to 800-426-6331, Ext, 215.
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
Immunohistochemistry reagents and kits - Product Code NJT
Causa
Novocastra liquid mouse monoclonal antibody calretinin when used in combination with specific lots of antibody diluent will give reduced staining.
Acción
A Medical Device Recall Notification letter was sent via e-mail on April 5, 2015 to the consignees describing the nature of the recall and action that needed to be taken. The firm requested that the consignees take the following actions:
Only use Novocastra Liquid Mouse Monoclonal Antibody Calretinin with the lot numbers of diluent specified.
There is no need for retrospective review of tissue staining if appropriate positive controls were properly used and interpreted during the immuno / in situ staining.
Complete and return the attached acknowledgment.
The firm requests that consignees contact their local Leica representative if they have any questions or concerns, or alternatively please contact the firm at the following e-mail address; LMGRA@leica-microsystems.com