Radiological Image Processing System The system is an recall
Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is…
Why was Radiological Image Processing System The system is an recalled?
The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrect position of the navigated instrument(s) versus the displayed reference image.
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?
E9-0002-G, ES-0013-G, E9-0036-G, E9-0040-G, E9-0041-G, ES-0014-G, ES-0016-G, ES-0033-G, ES-0043-G, ES-0041-G, ES-0042-G, ES-OO84-G, ES-0086-G, ES-0163-G, E9-0089-G, ES-0026-G, ES-0044-G
- Product
- Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is…
- Recalling firm
- GE OEC Medical Systems, Inc
- Quantity
- 17
- Distribution
- Worldwide Distribution - USA including MO, IL, LA, FL, NH, TX, IN, PA, NJ and the countries of France and China
- Recall date
- August 15, 2012
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)