GE Healthcare Allia IGS 7 OR recall
GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
Why was GE Healthcare Allia IGS 7 OR recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 00195278215550, Serial Numbers: D3-23-026, D4-24-002
- Product
- GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
- Recalling firm
- GE Medical Systems, SCS
- Quantity
- 2 units
- 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
- Recall date
- May 15, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)