Recall Z-1779-2024 ยท OWB Interventional Fluoroscopic X-Ray System
GE Medical Systems, SCS
GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
| Date | May 6, 2024 (initiated Mar 18, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 n |
| Quantity | 1 unit |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232344 | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR GE Medical Systems SCS, Oct 11, 2023 |