Reported Dec 25, 2024 · Ongoing
OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide…
GE OEC Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE OEC Medical Systems, Inc · 384 N Wright Brothers Dr · Salt Lake City, UT · 84116-2862
Is this the product you have?
- OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
- Lot codes and dates
- Product NameOEC 9800
- GTIN code00840682114349
- Lot/Serial Numbers / UDI codes82XXXX04237 (01)00840682114349(11)170600(21)82XXXX04237 8S-2249 Not Applicable-MFG date prior to UDI compliance requirement 89-1022 Not Applicable-MFG date prior to UDI compliance requirement 82-1772 Not Applicable-MFG date prior to UDI compliance requirement 82-0980 Not Applicable-MFG date prior to UDI compliance requirement 8S-1793 Not Applicable-MFG date prior to UDI compliance requirement 82-2349 Not Applicable-MFG date prior to UDI compliance requirement 82-3361 Not Applicable-MFG date prior to UDI compliance requirement 8S-1398 Not Applicable-MFG date prior to UDI compliance requirement 82-0908 Not Applicable-MFG date prior to UDI compliance requirement 82-0599 Not Applicable-MFG date prior to UDI compliance requirement 8S-0533 Not Applicable-MFG date prior to UDI compliance requirement 82-0189 Not Applicable-MFG date prior to UDI compliance requirement 8S-0186 Not Applicable-MFG date prior to UDI compliance requirement 89-2415 Not Applicable-MFG date prior to UDI compliance requirement 8S-3259 Not Applicable-MFG date prior to UDI compliance requirement 8S-3426 Not Applicable-MFG date prior to UDI compliance requirement 89-1530 Not Applicable-MFG date prior to UDI compliance requirement 82-2955 Not Applicable-MFG date prior to UDI compliance requirement 8S-0958-RC Not Applicable-MFG date prior to UDI compliance requirement 82-1154 Not Applicable-MFG date prior to UDI compliance requirement 8S-3032 Not Applicable-MFG date prior to UDI compliance requirement 8S-3145 Not Applicable-MFG date prior to UDI compliance requirement 89-1916-RC Not Applicable-MFG date prior to UDI compliance requirement 82-4134 Not Applicable-MFG date prior to UDI compliance requirement
- Amount recalled
- 25 systems
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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