CLASS II ONGOING Device recall · Reported 25 Dec 2024 · FDA Enforcement Report
OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System recalled
GE OEC Medical Systems is recalling OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The, distributed in 44 states. The recall was initiated on 21 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0705-2025
- FDA event ID
- 95846
- Recalling firm
- GE OEC Medical Systems, Salt Lake City, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Nov 2024
- FDA classified
- 18 Dec 2024
- Reported
- 25 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 21 Nov 2024 | Recall initiated by company | |
| 18 Dec 2024 | Classified by FDA | +27 days |
| 25 Dec 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
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
AlaskaArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMarylandMichiganMinnesotaMissouri
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 95846This product is part of a recall event; the main page for the event is OEC 3D recalled by GE OEC Medical Systems.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | OEC 3D recalled by GE OEC Medical Systems | GE OEC Medical Systems | Packaging Defects | 44 states | |
| CLASS II | OEC Elite recalled by GE OEC Medical Systems | GE OEC Medical Systems | Packaging Defects | 44 states | |
| CLASS II | OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System recalled | GE OEC Medical Systems | Packaging Defects | 44 states |
More recalls from GE OEC Medical Systems
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System recalled | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC Elite recalled by GE OEC Medical Systems | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC 3D recalled by GE OEC Medical Systems | GE OEC Medical Systems | Packaging Defects | 44 states |
| Device | CLASS II | OEC Elite Systems with Image Intensifier recalled | GE OEC Medical Systems | Other | Nationwide |
| Device | CLASS II | OEC 9800 Systems with Image Intensifier recalled | GE OEC Medical Systems | Other | Nationwide |
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| Device | CLASS II | Pipeline Flex Embolization Device with Shield Technology recalled | Micro Therapeutics | Labeling Errors | Nationwide |
| Device | CLASS II | System (RED 62 Reperfusion Catheter) recalled by Penumbra | Penumbra | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |