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
Mammographic X-Ray system - Product Code IZH
Causa
Ge healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. this issue occurs when an exam is performed in a specific angulated view associated with use of the stereotactic positioner of your senographe ds acquisition system and could impact patient safety. if the stereotactic positioner is removed when the examination arm is at 33 degrees and, th.
Acción
A Product Safety Notification letter, dated March 3, 2008, was sent to affected customers. The letter provided information about the safety issue, identified affected product and stated that GE Healthcare will provide a software upgrade.
Contact GE Healthcare at 1-262-544-3894 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
Slide stainer, automated - Product Code KPA
Causa
Ventana medical system is initiating the recall of the benchmark and discovery series instruments because there is a possibility that the heating element could separate from the underside of the heater cap and cause a non-staining or inconsistent staining event. additionally, the system may not detect this anomaly and therefore it may not generate an error message for the slide position.
Acción
Ventana sent an Urgent Medical Device Correction Notification letter dated June 16, 2008 to all affected customers. The letter identifed the affected product, problem and actions to be taken. The letter instructed customers to carefully read and perform all of the actions outlined in the notification letter concerning potential safety issue. Customers with concerns regarding the staining results on any patient specimen are instructed to follow their internal Quality Procedures regarding the review of patient reports. For question contact your local Customer Service Center.
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
Aseptic Transfer Set - Product Code GAZ
Causa
The mentor aseptic transfer set contains a component, the bd 60ml luer-lok syringe, which is under recall by becton dickinson due to a package integrity issue.
Acción
Firm sent notification, along with a copy of the Becton Dickinson recall letter, to consignees on 08/18/08. Consignees asked to inspect inventory of Mentor Aseptic Transfer Sets for affected BD 60mL syringes and to complete and return the included Device Accountability Worksheet. For additional information, please contact Mentor Customer Service at 800-235-5731.
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.
Ge healthcare has become aware that a few customers have experienced an unusual occurrence of system lockups on innova single plane cardiovascular x-ray imaging systems while using the image auto-archiving function. when occurring during x-ray imaging, the acquisition fails and the user has to rest the system. to date, one patient death has been reported related to this issue.
Acción
GE Healthcare sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Health Care Professionals describing the problem with the affected devices including instructions to avoid further problems until a GE Healthcare service representative is able to make contact and upgrade the system.
Further questions may be addressed by calling 1-800-437-1171.
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.
Tube support arm or the detecting mounting hardware may become loose at the joint with the telescope.
Acción
Updated Instructions were issued in August 2008 (AX049/08/S) to Siemens Service Engineers to have them inspect and tighten any loose hardware on the affected systems.
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.
Ge healthcare has become aware that a few customers have experienced an unusual occurrence of system lockups on innova single plane cardiovascular x-ray imaging systems while using the image auto-archiving function. when occurring during x-ray imaging, the acquisition fails and the user has to rest the system. to date, one patient death has been reported related to this issue.
Acción
GE Healthcare sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Health Care Professionals describing the problem with the affected devices including instructions to avoid further problems until a GE Healthcare service representative is able to make contact and upgrade the system.
Further questions may be addressed by calling 1-800-437-1171.
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.
Ge healthcare has become aware that a few customers have experienced an unusual occurrence of system lockups on innova single plane cardiovascular x-ray imaging systems while using the image auto-archiving function. when occurring during x-ray imaging, the acquisition fails and the user has to rest the system. to date, one patient death has been reported related to this issue.
Acción
GE Healthcare sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Health Care Professionals describing the problem with the affected devices including instructions to avoid further problems until a GE Healthcare service representative is able to make contact and upgrade the system.
Further questions may be addressed by calling 1-800-437-1171.
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
Angiographic X-ray System - Product Code IZI
Causa
Patients could possibly fall off the table if not properly secured when: 1) moving them onto the patient table, 2) moving them on the patient table or 3) removing them from the patient table.
Acción
The recalling firm issued a Customer Safety Advisory Notice dated 7/04/08 (including an Addendum to the Operators Manual) which alerts the operator of possible injury to patients if they are not properly secured to the table during examinations and describes the recommended fastening procedures required to properly secure the patient to the table.
For questions or additional information, contact Siemens Medical Solutions, Inc. at 610-448-4634.
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
Angiographic X-ray System - Product Code IZI
Causa
Patients could possibly fall off the table if not properly secured when: 1) moving them onto the patient table, 2) moving them on the patient table or 3) removing them from the patient table.
Acción
The recalling firm issued a Customer Safety Advisory Notice dated 7/04/08 (including an Addendum to the Operators Manual) which alerts the operator of possible injury to patients if they are not properly secured to the table during examinations and describes the recommended fastening procedures required to properly secure the patient to the table.
For questions or additional information, contact Siemens Medical Solutions, Inc. at 610-448-4634.
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
X-Ray System - Product Code KPR
Causa
The actual average illuminance for the collimators are approximately 140-lux. this does not meet the 160-lux requirement. ge will be correcting the units by replacing all collimators.
Acción
GE will be correcting the units by replacing all collimators that don't meet the 160-lux requirement. The field correction will be initiated and is scheduled to be completed by October 2008.
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
fluoroscopic x-ray system - Product Code JAA
Causa
Possible overexposure: failure to apply the entrance exposure rate (eer) tube current limit calibration to the automatic exposure rate (aer) control system when the anatomical profile mode is changed from the default selection to another selection. manual technique modes are not affected.
Acción
GE OEC sent a letter to customers December 15, 2007, and scheduled field representative visits for corrective software solution installation.
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 MQB
Causa
Software error, computer: ge healthcare has became aware of an issue with error management affecting the innova 2100, 3100/3100 iq & 4100/4100iq. it was reported that when the foot switch was pressed, the live monitor screen was blank and it looked like there were no x-rays being emitted. but the message "acquisition in progress" was displayed on the dl monitor, even after the foot switch was r.
Acción
Consignees sent a "GE Urgent Medical Device Correction" letter dated February 28, 2008. The letter was addressed to Hospital Administrators/Hospital Risk Management Department/Managers of Radiology-Cardiology/ Radiologists-Cardiologists. The letter described the affected products, safety Issue, short term recommendations, long term solution and contact Information. The first batch of letters was received by customers on 5/28/08. For further information, please contact GE Healthcare at 262-544-3894
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 MQB
Causa
Software error, computer: ge healthcare has became aware of an issue with error management affecting the innova 2100, 3100/3100 iq & 4100/4100iq. it was reported that when the foot switch was pressed, the live monitor screen was blank and it looked like there were no x-rays being emitted. but the message "acquisition in progress" was displayed on the dl monitor, even after the foot switch was r.
Acción
Consignees sent a "GE Urgent Medical Device Correction" letter dated February 28, 2008. The letter was addressed to Hospital Administrators/Hospital Risk Management Department/Managers of Radiology-Cardiology/ Radiologists-Cardiologists. The letter described the affected products, safety Issue, short term recommendations, long term solution and contact Information. The first batch of letters was received by customers on 5/28/08. For further information, please contact GE Healthcare at 262-544-3894
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
Ge healthcare has become aware of a potential condition that may impact operator or patient safety. one customer has reported that inability to terminate x-ray exposure after releasing the hand switch control (located in the control room).
Acción
An Urgent Medical Device Correction letter, dated June 2008 was sent to customers The letter described the issue, affected products and provided short term user recommendations. GE developed a new software release that corrects this condition and will launch the corrective action to upgrade all affected systems.
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 MQB
Causa
Software error, computer: ge healthcare has became aware of an issue with error management affecting the innova 2100, 3100/3100 iq & 4100/4100iq. it was reported that when the foot switch was pressed, the live monitor screen was blank and it looked like there were no x-rays being emitted. but the message "acquisition in progress" was displayed on the dl monitor, even after the foot switch was r.
Acción
Consignees sent a "GE Urgent Medical Device Correction" letter dated February 28, 2008. The letter was addressed to Hospital Administrators/Hospital Risk Management Department/Managers of Radiology-Cardiology/ Radiologists-Cardiologists. The letter described the affected products, safety Issue, short term recommendations, long term solution and contact Information. The first batch of letters was received by customers on 5/28/08. For further information, please contact GE Healthcare at 262-544-3894
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
Ge healthcare has become aware of a potential condition that may impact operator or patient safety. one customer has reported that inability to terminate x-ray exposure after releasing the hand switch control (located in the control room).
Acción
An Urgent Medical Device Correction letter, dated June 2008 was sent to customers The letter described the issue, affected products and provided short term user recommendations. GE developed a new software release that corrects this condition and will launch the corrective action to upgrade all affected systems.
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
computed tomography x-ray system - Product Code JAK
Causa
Excessive radiation: intermittent shifting of ct numbers causes the actual dose to the patient to be greater than expected, when sure exposure option is used.
Acción
Toshiba sent a letter to customers in July 2007, and sent field service representatives to update the Data Aquisition System in September/October 2007.
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
Implantable clip - Product Code FZP
Causa
A hole in the sterile unit blister pack was detected that would compromise sterility.
Acción
Consignees were notified via UPS next day on/about August 22, 2008. They were instructed to cease use and distribution and quarantine all affected product immediately. If they have any of the affected product they were instructed to return all it to Teleflex Medical via provided UPS-Ground. An Acknowledgement form was provided to be completed and returned via fax to Teleflex Medical to confirm receipt of the notification and amount of product on hand for return. A second mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks from the second mailing. Consignees also may be contacted by phone, e-mail, or fax. A record of these contacts will be maintained. Upon return to Teleflex Medical, product will be quarantined, assessed for recall effectiveness, and either reworked or destroyed. Contact Telefex Medical at 1-800-334-9751 ext. 8066 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
Custom surgical kit - Product Code KDD
Causa
Surgical kits contained a recalled endopath etx 35 mm endoscopic linear cutter white reload/cartridges.
Acción
The firm sent out recall notices to their sales representatives, the distributors, and the hospitals addressed to the Recall Coordinator/OR Supervisor on 10/2/08. These notices stated that the recalling firm's sales representatives would perform the field correction in lieu of returning the kits. Contact DeRoyal Industries, Inc. at 1-865-362-6157 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
Custom surgical kit - Product Code KDD
Causa
Surgical kits contained a recalled endopath etx 35 mm endoscopic linear cutter white reload/cartridges.
Acción
The firm sent out recall notices to their sales representatives, the distributors, and the hospitals addressed to the Recall Coordinator/OR Supervisor on 10/2/08. These notices stated that the recalling firm's sales representatives would perform the field correction in lieu of returning the kits. Contact DeRoyal Industries, Inc. at 1-865-362-6157 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.
Gyrus ACMI initiated a voluntary recall by an Urgent: Medical Device Recall letter on 10/01/08 informing accounts of the problem, cease any further use of the affected product, remove any of the affected product service representative to obtain a Return Goods Authorization, return the product, and complete the reply form and fax it to the Regulatory Affairs Dept. so that the response can be tracked.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
introducer set - Product Code DYB
Causa
Difficulty breaking the sheath hub and subsequently to peel the sheath off for introducer set, adelante size 7f.
Acción
Oscor notified the Direct Account by letter on 07/03/2008. Direct account was asked to return all unused Introducers back to Oscor. All returned products should be labeled with the Return Goods Product number.
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
Glycosylated Hemoglobin Assay - Product Code LCP
Causa
Internal studies observed occasional unexpected outlier results in whole blood samples tested for hemoglobin a1c using the eza1c reagent on the ace or ace alera clinical chemistry systems.
Acción
An initial URGENT: CUSTOMER ADVISORY NOTICE dated August 22, 2008 was sent to all customers and distributors. The letter stated the problem and asked customers to cease using the EZA1C reagent, controls and calibrators. Customers were asked to hold any affected inventory while additional testing was conducted by Alfa Wassermann Diagnostic Technologies, LLC. (AWDT). A second communication, URGENT: CUSTOMER ADVISORY NOTICE (and Product Response Form) dated September 18, 2008 was sent instructing customers to destroy all product and package inserts in stock for the EZA1C products listed in the letter. Information was provided on receiving credit and an alternative product for use. Customers are requested to complete and return the Product Response Form by fax (888-646-2535) to AWDT indicating their receipt of the letter and the amount of product destroyed. Distributors' letters requested their customers be notified of the recall and that the Product Response Form be sent directly to AWDT. Direct questions to AWDT Customer Solution Center at 866-419-2532.
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
Angiographic x-ray system - Product Code IZI
Causa
System may switch to emergency fluoroscopy mode.
Acción
A Customer Safety Advisory Letter dated 8/20/08 was issued with Update Instructions AX045/08/S. The letter informed the customer of the potential issue and provided instruction to avoid its occurrence. A software update (VB31E) was released to correct the 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.
Notas adicionales en la data
Angiographic x-ray system - Product Code IZI
Causa
System may switch to emergency fluoroscopy mode.
Acción
A Customer Safety Advisory Letter dated 8/20/08 was issued with Update Instructions AX045/08/S. The letter informed the customer of the potential issue and provided instruction to avoid its occurrence. A software update (VB31E) was released to correct the issue.