892.1650 Image-intensified fluoroscopic x-ray system recall
892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imaging of the patient during…
Why was 892.1650 Image-intensified fluoroscopic x-ray system recalled?
GE OEC is recalling certain 9800 Image Intensified Flouroscopic x-ray systems due to customer complaint analysis showing that a replacement Hitachi 160 GB Hard Drive, when installed on certain models is susceptible of causing unanticipated system shut downs, no boots, data loss or data mix, or unexpected hard drive corruption.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Model Number HDS721616PLAT80; GE Healthcare part number 5304649.
- Product
- 892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imaging of the patient during…
- Recalling firm
- GE OEC Medical Systems, Inc
- Quantity
- 3,595 units
- Distribution
- Worldwide Distribution -- USA (nationwide)
- Recall date
- August 29, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)