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
General surgery tray (kit) - Product Code LRO
Causa
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Acción
Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.
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
Pump, infusion - Product Code FRN
Causa
Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.
Acción
Elite Biomedical Solutions, sent a "Product Advisory Notices" letter dated May 21, 2015 to their customers. On June 3, 2015 the firm sent an Urgent Medical Device Recall letter to their customers. The letter identified the affected product , problem and actions to be taken. And on June 12, 2015 a press release was issued via ECRI (Emergency Care Research Institute) to all hospitals in the US. The notification letter requested customers to: 1) inspect and quarantine affected products, 2) identify your customers and notify them at once of this product recall, and 3) complete and return the enclosed response forms. For any questions, call Elite Biomedical Solutions, LLC, Quality Manager, at 1-855-291-6701.
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
Forceps, wire holding - Product Code HYA
Causa
Medium bone plate forceps was assembled with the incorrect grip arm tip. potential that the surgeon will be unable to provisionally clamp the plate to the patient's bone.
Acción
On 6/17/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for locating and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
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
Computer-assisted personalized sedation system - Product Code PDR
Causa
Ethicon has found that disinfecting methods not specified in the instructions for use (ifu) have led to the degradation of the plastic material of the sedasys system control unit.
Acción
Sedasys, a Division of Ethicon Endo-Surgery, Inc. sent an Urgent Customer Notification letter dated May 27, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to do the following:
1. Please distribute this information to all staff within your facility who use the SEDASYS System
2. Complete the Business Reply Form (BRF) (Attachment A) confirming receipt of this notice within three (3) business days. The BRF may be given to your sales or service representative or sent to Sedasys by email at SedasysTechSupport@its.jnj.com.
3. Keep this notice visibly posted in your facility for awareness.
4. If you have any questions or concerns regarding the condition of your SEDASYS System including the Control Units, please contact your Sales or Service Representative.
If you need clinical or product support, please contact your local sales representative or call our Customer Support Center at 1-800-SEDASYS (1-800-733-2797). If you need additional communications packages, contact 1-800-SEDASYS and reference Event 052715SED01.
For questions regarding this recall call 513-337-7439.
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.
Acon laboratories, inc. is recalling mission breath alcohol detector due to a labeling amendment.
Acción
On 06/17/15 the firm sent out customer notification letters to their distributors. The letter identified the affected product, problem and actions to be taken. In the letter the firm requests that Mission Breath Alcohol Detectors be quarantined. The firm asks that distributor complete the "fax back" form to allow for the return of unexpired product for a replacement. Once the form is received the firm is going to issue a return authorization number as well as provide a return label.
The contact noted in the letter is Qiyi Xie MD, MPH, Sr. Officer Regulatory and Clinical Affairs at 858-857-8011.
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.
One dimension of the affected instrument is incorrect. therefore this instrument cannot be used to remove the metal adapter as intended.
Acción
A customer notification letter dated 6/22/15 will be sent to all customers who purchased the Abutment Retrieval Instrument Zirconia CC RP/WP because an internal investigation showed that one dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended. The letter provides the problems identified and the actions to be taken. Customers are instructed to complete the acknowledgement form and return it to their local Nobel Biocare Subsidiary with the affected instrument. Customers with the affected instrument that is a part of a kit, Nobel Biocare Representative will contact them directly. Customers with any remaining questions, are instructed to contact their Nobel Biocare 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
Screw, fixation, bone - Product Code HWC
Causa
Scfe drivers of the free-gliding scfe screw system are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation.
Acción
Pega Medical sent an Urgent Field Safety-Recall letter via email on June 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Advise on action to be taken by the customer:
¿ Identify the device with the same catalogue number and lot number
¿ Return the device to Pega Medical Inc. to the address shown below using the FedEx account.
For further questions please call the firm at 450-688-5144 x. 242.
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
Pin, fixation, threaded - Product Code JDW
Causa
Musculoskeletal transplant foundation (mtf) is recalling one lot of mtf's allograft cortical pins because the lot was labeled as a 2.0 mm diameter pin and it may contain a 2.4 mm diameter pin.
Acción
Musculoskeletal Transplant Foundation initiated this recall by either telephoning their customers or by sending a recall letter dated 5/27/15 to the customer.
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, angiographic - Product Code IZI
Causa
Ge healthcare has recently become aware of a potential safety issue that may result in the loss of c-arm gantry motion capability on fluoroscopic interventional imaging systems (innova, optima and discovery).
Acción
The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling.
GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction.
If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Interventional fluoroscopic x-ray system - Product Code OWB
Causa
Ge healthcare has recently become aware of a potential safety issue that may result in the loss of c-arm gantry motion capability on fluoroscopic interventional imaging systems (innova, optima and discovery).
Acción
The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling.
GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction.
If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, x-ray, angiographic - Product Code IZI
Causa
Ge healthcare has recently become aware of a potential safety issue that may result in the loss of c-arm gantry motion capability on fluoroscopic interventional imaging systems (innova, optima and discovery).
Acción
The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling.
GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction.
If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, x-ray, angiographic - Product Code IZI
Causa
Ge healthcare has recently become aware of a potential safety issue that may result in the loss of c-arm gantry motion capability on fluoroscopic interventional imaging systems (innova, optima and discovery).
Acción
The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling.
GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction.
If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, x-ray, angiographic - Product Code IZI
Causa
Ge healthcare has recently become aware of a potential safety issue that may result in the loss of c-arm gantry motion capability on fluoroscopic interventional imaging systems (innova, optima and discovery).
Acción
The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling.
GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction.
If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, x-ray, angiographic - Product Code IZI
Causa
Ge healthcare has recently become aware of a potential safety issue that may result in the loss of c-arm gantry motion capability on fluoroscopic interventional imaging systems (innova, optima and discovery).
Acción
The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling.
GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction.
If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, x-ray, angiographic - Product Code IZI
Causa
Ge healthcare has recently become aware of a potential safety issue that may result in the loss of c-arm gantry motion capability on fluoroscopic interventional imaging systems (innova, optima and discovery).
Acción
The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling.
GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction.
If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, x-ray, angiographic - Product Code IZI
Causa
Ge healthcare has recently become aware of a potential safety issue that may result in the loss of c-arm gantry motion capability on fluoroscopic interventional imaging systems (innova, optima and discovery).
Acción
The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling.
GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction.
If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, x-ray, angiographic - Product Code IZI
Causa
Ge healthcare has recently become aware of a potential safety issue that may result in the loss of c-arm gantry motion capability on fluoroscopic interventional imaging systems (innova, optima and discovery).
Acción
The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling.
GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction.
If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, x-ray, angiographic - Product Code IZI
Causa
Ge healthcare has recently become aware of a potential safety issue that may result in the loss of c-arm gantry motion capability on fluoroscopic interventional imaging systems (innova, optima and discovery).
Acción
The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling.
GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction.
If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, x-ray, angiographic - Product Code IZI
Causa
Ge healthcare has recently become aware of a potential safety issue that may result in the loss of c-arm gantry motion capability on fluoroscopic interventional imaging systems (innova, optima and discovery).
Acción
The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling.
GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction.
If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, x-ray, angiographic - Product Code IZI
Causa
Ge healthcare has recently become aware of a potential safety issue that may result in the loss of c-arm gantry motion capability on fluoroscopic interventional imaging systems (innova, optima and discovery).
Acción
The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling.
GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction.
If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Gardner Denver Thomas sent an Important Medical Device Recall letter dated May 7, 2015 to affected distributors. The letter identified the affected products, problem and actions to be taken. For questions call your Customer Service Representative or Sales Representative or the Recall Coordinator at 920-451-6423.
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.
Gardner Denver Thomas sent an Important Medical Device Recall letter dated May 7, 2015 to affected distributors. The letter identified the affected products, problem and actions to be taken. For questions call your Customer Service Representative or Sales Representative or the Recall Coordinator at 920-451-6423.
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.
Gardner Denver Thomas sent an Important Medical Device Recall letter dated May 7, 2015 to affected distributors. The letter identified the affected products, problem and actions to be taken. For questions call your Customer Service Representative or Sales Representative or the Recall Coordinator at 920-451-6423.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Calculator/data processing module, for clinical use - Product Code JQP
Causa
For paragon laboratory management 12.1 and 12.1.1 releases, if used with microsoft sql server 2012, the final cumulative report may incorrectly display the data.
Acción
McKesson issued a Clinical Alert to notify customers of the issue on June 15, 2015, and requested that customers disable Cumulative Reporting. McKesson is identifying customers currently in a live environment with Microsoft SQL Server 2012 and the affected configuration. McKesson will provide those customers with corrective software, and provide assistance in generating correct reports and updating those to the patient folder. For further questions, please call (404) 338-3556.
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 sfd/idd safety mechanism may not engage properly at the lower range of sfd/idd travel. this mechanism is installed to hold and prevent the sfd/idd from falling due to a counterweight cable failure. the lower range of travel is 1.1 in (28mm) from the lowest point of normal sfd/idd vertical compression. a fall of the sfd/idd could result in an injury to a patient or operator.
Acción
GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref#10902 dated June 12, 2015 to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.