GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
Recall
- Recall Number
- Z-1781-2024
- Event Number
- 94305
- Firm
- GE Medical Systems, SCS
- FEI Number
- 1000284313
- Product Code
- OWB
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- March 18, 2024
- Posted
- May 6, 2024
- Address
- 283 rue de la Miniere Buc France
Description
GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
GE Healthcare issued an UGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/18/2024 via letter. The notice explained the issue, hazard, and requested the following actions be taken: Every day prior to first use of the device, perform a functional check of the gantry movements and images of your device to look for the following behaviors: 1. Abnormal noise during gantry movement. 2. Image misalignment. If any of the above is observed, DO NOT use the device and call GE HealthCare Service Immediately. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Post this letter in a visible location beside the product. GE HealthCare will schedule a service appointment to correct this potential issue in a timely manner. For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Worldwide distribution - US Nationwide in the states of CA, FL, GA, IN, MA, NC, OK, SC, TN, TX, VA and the countries of Armenia, China, France, Hungary, India, Italy, Japan, Kazakhstan, Lithuania, Mexico, Russia, Spain, Taiwan, Turkey, Vietnam
2 units