CLASS II ONGOING Device recall · Reported 25 Dec 2024 · FDA Enforcement Report
OEC Elite recalled by GE OEC Medical Systems
GE OEC Medical Systems is recalling OEC Elite, 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-0704-2025
- 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
- Surgical Instruments
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 Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical 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 Elite GTIN code: 00001234567895 Lot/Serial Numbers / UDI codes: FAXXXE00254 (01)00840682121729(11)190400(21)FAXXXE00254 FBHXTX00837 (01)00840682121729(11)230300(21)FBHXTX00837 FBHXTX00912 (01)00840682121729(11)230500(21)FBHXTX00912 FBHXTX01278 (01)00840682121729(11)240800(21)FBHXTX01278 FBXXXE00731 (01)00840682121729(11)190500(21)FBXXXE00731 FBMHTX00470 (01)00840682121729(11)240900(21)FBMHTX00470 F2XXTX00801 (01)00840682121729(11)240800(21)F2XXTX00801 FBHXXX00171 (01)00840682121729(11)180600(21)FBHXXX00171 FBXXXE00715 (01)00840682121729(11)190500(21)FBXXXE00715 FBMHTX00444 (01)00840682121729(11)240600(21)FBMHTX00444 FBXXTE02974 (01)00840682121729(11)240800(21)FBXXTE02974 FBMHTX00466 (01)00840682121729(11)240900(21)FBMHTX00466 FAXXTE00672 (01)00840682121729(11)221200(21)FAXXTE00672 F9XXTX00276 (01)00840682121729(11)230900(21)F9XXTX00276 FAXXTE01160 (01)00840682121729(11)240800(21)FAXXTE01160 FBMHTX00454 (01)00840682121729(11)240800(21)FBMHTX00454 FBMHTX00455 (01)00840682121729(11)240800(21)FBMHTX00455 FBMHTX00465 (01)00840682121729(11)240900(21)FBMHTX00465 FBXXTE02975 (01)00840682121729(11)240800(21)FBXXTE02975 FBXXTE02976 (01)00840682121729(11)240800(21)FBXXTE02976 FBXXXE00312 (01)00840682121729(11)180900(21)FBXXXE00312 FAXXTE00664 (01)00840682121729(11)221100(21)FAXXTE00664 FBMHTX00450 (01)00840682121729(11)240700(21)FBMHTX00450 FAXXTE01154 (01)00840682121729(11)240700(21)FAXXTE01154 FBXXTE02994 (01)00840682121729(11)240800(21)FBXXTE02994 FAXXTE00544 (01)00840682121729(11)220600(21)FAXXTE00544 FBXXTE01055 (01)00840682121729(11)211200(21)FBXXTE01055 FBXXTE02966 (01)00840682121729(11)240800(21)FBXXTE02966 FBMHTX00467 (01)00840682121729(11)240900(21)FBMHTX00467 FAXXTE00339 (01)00840682121729(11)210600(21)FAXXTE00339 FSXXTX00282 (01)00840682121729(11)220500(21)FSXXTX00282 FAXXXE00231 (01)00840682121729(11)190300(21)FAXXXE00231 FBXXXE00653 (01)00840682121729(11)190400(21)FBXXXE00653 F2XXTX00381 (01)00840682121729(11)220100(21)F2XXTX00381 FBXXXE00008 (01)00840682121729(11)171000(21)FBXXXE00008 FBMHTX00468 (01)00840682121729(11)240900(21)FBMHTX00468 FBXXTP00008 (01)00840682121729(11)240700(21)FBXXTP00008 FSXXTX00501 (01)00840682121729(11)240400(21)FSXXTX00501 F2XXTX00802 (01)00840682121729(11)240800(21)F2XXTX00802 FAXXTE01157 (01)00840682121729(11)240700(21)FAXXTE01157 FBMHTX00447 (01)00840682121729(11)240600(21)FBMHTX00447 FBMHDX00049 (01)00195278096944(11)220100(21)FBMHDX00049 FBXXTE02312 (01)00840682121729(11)230900(21)FBXXTE02312 F9XXTX00301 (01)00840682121729(11)240100(21)F9XXTX00301 FBXXTE02965 (01)00840682121729(11)240800(21)FBXXTE02965 FBXXXE00654 (01)00840682121729(11)190400(21)FBXXXE00654 FBMHTX00452 (01)00840682121729(11)240800(21)FBMHTX00452 FBXXTE00561 (01)00840682121729(11)201100(21)FBXXTE00561 FBXXTE02963 (01)00840682121729(11)240800(21)FBXXTE02963 FBXXTE02109 (01)00840682121729(11)230600(21)FBXXTE02109 FBXXTP00006 (01)00840682121729(11)240700(21)FBXXTP00006 FBXXTP00007 (01)00840682121729(11)240700(21)FBXXTP00007 F2XXTX00021 (01)00840682121729(11)191100(21)F2XXTX00021 FBXXTE02991 (01)00840682121729(11)240800(21)FBXXTE02991 FBXXTE02992 (01)00840682121729(11)240800(21)FBXXTE02992 F2XXTX00799 (01)00840682121729(11)240800(21)F2XXTX00799 FSXXTX00514 (01)00840682121729(11)240600(21)FSXXTX00514 FBXXTE01754 (01)00840682121729(11)230100(21)FBXXTE01754 FBXXTE02914 (01)00840682121729(11)240600(21)FBXXTE02914 FBXXTE00515 (01)00840682121729(11)201000(21)FBXXTE00515 FAXXXE00049 (01)00840682121729(11)180200(21)FAXXXE00049 FBXXXE00272 (01)00840682121729(11)180900(21)FBXXXE00272 FSXXXX00004 (01)00840682121729(11)190400(21)FSXXXX00004 FBMHTX00433 (01)00840682121729(11)240400(21)FBMHTX00433 FBMHTX00446 (01)00840682121729(11)240600(21)FBMHTX00446 FBXXTE01644 (01)00840682121729(11)221200(21)FBXXTE01644 FBMHTX00464 (01)00840682121729(11)240900(21)FBMHTX00464 FBXXTE02978 (01)00840682121729(11)240800(21)FBXXTE02978 F2XXTX00798 (01)00840682121729(11)240800(21)F2XXTX00798 FBXXTE02979 (01)00840682121729(11)240800(21)FBXXTE02979 FBXXTE01932 (01)00840682121729(11)230300(21)FBXXTE01932 FBXXTE02977 (01)00840682121729(11)240800(21)FBXXTE02977 FBXXTE02993 (01)00840682121729(11)240800(21)FBXXTE02993 FBHXTX00821 (01)00840682121729(11)230200(21)FBHXTX00821 F2XXTX00800 (01)00840682121729(11)240800(21)F2XXTX00800 FSXXTX00284 (01)00840682121729(11)220500(21)FSXXTX00284 FBXXTE00575 (01)00840682121729(11)201200(21)FBXXTE00575 FBMHTX00469 (01)00840682121729(11)240900(21)FBMHTX00469 FBXXTE02323 (01)00840682121729(11)230900(21)FBXXTE02323 FSXXTX00422 (01)00840682121729(11)230300(21)FSXXTX00422 FAHXTX00538 (01)00840682121729(11)240600(21)FAHXTX00538 FBXXTE02996 (01)00840682121729(11)240800(21)FBXXTE02996 FSXXTX00418 (01)00840682121729(11)230300(21)FSXXTX00418 FBXXTE01863 (01)00840682121729(11)230300(21)FBXXTE01863 FBMHTX00453 (01)00840682121729(11)240800(21)FBMHTX00453 FBMHTX00329 (01)00840682121729(11)230200(21)FBMHTX00329 FAXXTE01158 (01)00840682121729(11)240800(21)FAXXTE01158 FBXXTE02995 (01)00840682121729(11)240800(21)FBXXTE02995 FAXXTE01159 (01)00840682121729(11)240800(21)FAXXTE01159 F9XXXX00064 (01)00840682121729(11)191200(21)F9XXXX00064 FBXXTE02980 (01)00840682121729(11)240800(21)FBXXTE02980 FBXXTE02981 (01)00840682121729(11)240800(21)FBXXTE02981 FBXXTE02982 (01)00840682121729(11)240800(21)FBXXTE02982 FBXXTE02983 (01)00840682121729(11)240800(21)FBXXTE02983 FBXXTE02984 (01)00840682121729(11)240800(21)FBXXTE02984 FBXXTE02986 (01)00840682121729(11)240800(21)FBXXTE02986 FBXXTE02987 (01)00840682121729(11)240800(21)FBXXTE02987 FBMHTX00456 (01)00840682121729(11)240800(21)FBMHTX00456 FBMHTX00449 (01)00840682121729(11)240700(21)FBMHTX00449 F9XXTX00329 (01)00840682121729(11)240800(21)F9XXTX00329
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 9900 REF Image-Intensified Fluoroscopic X-Ray System recalled | 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 9900 REF Image-Intensified Fluoroscopic X-Ray System recalled | 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 | Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy | Karl Storz Endoscopy | Packaging Defects | Nationwide |
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| Device | CLASS II | Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled | ASP Global | Device Malfunction | Nationwide |