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OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile f...

FDA Device Recall #Z-0705-2025 — Class II — November 21, 2024

Recall Summary

Recall Number Z-0705-2025
Classification Class II — Moderate risk
Date Initiated November 21, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm GE OEC Medical Systems, Inc
Location Salt Lake City, UT
Product Type Devices
Quantity 78 systems

Product Description

OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

Reason for Recall

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.

Distribution Pattern

U.S.: AK, AZ, CA, CO, CT, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Australia, Brazil, Canada, Chile, Costa Rica, India, Italy, Philippines, Poland, Portugal, Sweden, Switzerland, and United Kingdom

Lot / Code Information

Product Name: OEC 9900 GTIN code: 00840682114301 Lot/Serial Numbers / UDI codes: E2-0345 Not Applicable-MFG date prior to UDI compliance requirement E2-7031-MH Not Applicable-MFG date prior to UDI compliance requirement E2-1862 Not Applicable-MFG date prior to UDI compliance requirement ES-0942 Not Applicable-MFG date prior to UDI compliance requirement E9-1101 Not Applicable-MFG date prior to UDI compliance requirement E9-2173 Not Applicable-MFG date prior to UDI compliance requirement E9-2706 Not Applicable-MFG date prior to UDI compliance requirement E2-5146 Not Applicable-MFG date prior to UDI compliance requirement E2-1777 Not Applicable-MFG date prior to UDI compliance requirement E2XXXX05533 (01)00840682114301(11)160600(21)E2XXXX05533 ES-3271 Not Applicable-MFG date prior to UDI compliance requirement E2XXXX05700 (01)00840682114301(11)160900(21)E2XXXX05700 E2XXXX06210 (01)00840682114301(11)170900(21)E2XXXX06210 E2MHXX07986 (01)00840682114301(11)170500(21)E2MHXX07986 E9-2586 Not Applicable-MFG date prior to UDI compliance requirement ES-1901 Not Applicable-MFG date prior to UDI compliance requirement E9-2999 Not Applicable-MFG date prior to UDI compliance requirement ESXXXX04466 (01)00840682114301(11)190100(21)ESXXXX04466 ES-2359 Not Applicable-MFG date prior to UDI compliance requirement E9-1824 Not Applicable-MFG date prior to UDI compliance requirement E2-4112 Not Applicable-MFG date prior to UDI compliance requirement E2-0633 Not Applicable-MFG date prior to UDI compliance requirement E9-0156 Not Applicable-MFG date prior to UDI compliance requirement ES-3537 Not Applicable-MFG date prior to UDI compliance requirement ES-0348 Not Applicable-MFG date prior to UDI compliance requirement ES-1269 Not Applicable-MFG date prior to UDI compliance requirement E9-2634 Not Applicable-MFG date prior to UDI compliance requirement E9-0763 Not Applicable-MFG date prior to UDI compliance requirement E2MHXX07958 (01)00840682114301(11)160900(21)E2MHXX07958 E2-4224 Not Applicable-MFG date prior to UDI compliance requirement E2XXXX05753 (01)00840682114301(11)161000(21)E2XXXX05753 ES-0186 Not Applicable-MFG date prior to UDI compliance requirement ES-1648 Not Applicable-MFG date prior to UDI compliance requirement ESXXXX04227 (01)00840682114301(11)170800(21)ESXXXX04227 ES-2800 Not Applicable-MFG date prior to UDI compliance requirement E2-2074 Not Applicable-MFG date prior to UDI compliance requirement E9XXXX03158 (01)00840682114301(11)170100(21)E9XXXX03158 ES-1390 Not Applicable-MFG date prior to UDI compliance requirement ESXXXX03869 (01)00840682114301(11)160800(21)ESXXXX03869 E9XXXX03157 (01)00840682114301(11)170100(21)E9XXXX03157 E2XXXX06067 (01)00840682114301(11)170400(21)E2XXXX06067 ES-1476 Not Applicable-MFG date prior to UDI compliance requirement ES-0317 Not Applicable-MFG date prior to UDI compliance requirement ES-1011 Not Applicable-MFG date prior to UDI compliance requirement E2-3459 Not Applicable-MFG date prior to UDI compliance requirement ES-0144 Not Applicable-MFG date prior to UDI compliance requirement ES-0336 Not Applicable-MFG date prior to UDI compliance requirement E9-2976 Not Applicable-MFG date prior to UDI compliance requirement E2-7081-MH Not Applicable-MFG date prior to UDI compliance requirement E2-4029 Not Applicable-MFG date prior to UDI compliance requirement E2-4133 Not Applicable-MFG date prior to UDI compliance requirement E2-5039 Not Applicable-MFG date prior to UDI compliance requirement E2-7161-MH Not Applicable-MFG date prior to UDI compliance requirement E2-4550 Not Applicable-MFG date prior to UDI compliance requirement E9-1488 Not Applicable-MFG date prior to UDI compliance requirement E2-4026 Not Applicable-MFG date prior to UDI compliance requirement E2XXXX05597 (01)00840682114301(11)160600(21)E2XXXX05597 E2-4617 Not Applicable-MFG date prior to UDI compliance requirement ES-0515 Not Applicable-MFG date prior to UDI compliance requirement E2-2621 Not Applicable-MFG date prior to UDI compliance requirement E9-1434 Not Applicable-MFG date prior to UDI compliance requirement E2-2531 Not Applicable-MFG date prior to UDI compliance requirement E2-1272 Not Applicable-MFG date prior to UDI compliance requirement ES-1439 Not Applicable-MFG date prior to UDI compliance requirement E9-2364 Not Applicable-MFG date prior to UDI compliance requirement ES-2273 Not Applicable-MFG date prior to UDI compliance requirement ES-2603 Not Applicable-MFG date prior to UDI compliance requirement E2-0371 Not Applicable-MFG date prior to UDI compliance requirement E2XXXX05573 (01)00840682114301(11)160600(21)E2XXXX05573 E9-2096 Not Applicable-MFG date prior to UDI compliance requirement ES-0717 Not Applicable-MFG date prior to UDI compliance requirement E2XXXX05451 (01)00840682114301(11)160500(21)E2XXXX05451 E9XXXX03164 (01)00840682114301(11)170100(21)E9XXXX03164 E2-4265 Not Applicable-MFG date prior to UDI compliance requirement E9-2471 Not Applicable-MFG date prior to UDI compliance requirement E2XXXX06639 (01)00840682114301(11)181000(21)E2XXXX06639 E9-2720 Not Applicable-MFG date prior to UDI compliance requirement E9-2710 Not Applicable-MFG date prior to UDI compliance requirement

Other Recalls from GE OEC Medical Systems, Inc

Recall # Classification Product Date
Z-0703-2025 Class II OEC 3D REF Image-Intensified Fluoroscopic X... Nov 21, 2024
Z-0706-2025 Class II OEC 9800 REF Image-Intensified Fluoroscopic... Nov 21, 2024
Z-0704-2025 Class II OEC Elite REF Image-Intensified Fluoroscopi... Nov 21, 2024
Z-2277-2023 Class II OEC 9900 Systems with 9-inch Image Intensifier May 15, 2023
Z-2275-2023 Class II OEC Flexiview 8800 Systems with 9-inch Image In... May 15, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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