Z-0705-2025Class II

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

Name: Z-0705-2025 OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy...
Creator: GE OEC Medical Systems, Inc
Published: 2024-11-21
License: https://open.fda.gov/license/

GE Healthcare / initiated 2024-11-21 / Open, Classified / root cause: manufacturing process

FDA source

GE OEC Medical Systems, Inc began a recall of OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and... on 2024-11-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0705-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-21
Posted: 2024-12-18
Recalling firm: GE Healthcare
Product: 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.
Product code: OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 11/21/2024, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter informing customers that GE HealthCare has become aware that recently manufactured OEC Elite and OEC 3D mobile C-arms, as well as recently replaced X-ray tubes on certain OEC Elite, OEC 3D and OEC 9900/OEC 9800 mobile C-arms potentially have insufficient sealing that can result in an oil leak. This issue could result in loss of fluoroscopic imaging capability. Customers are instructed to: 1.Continue to use their OEC Elite, OEC 3D, OEC 9900 and/or OEC9800 mobile C-arm. 2.If oil is found leaking from the X-ray tube on their OEC Elite, OEC 3D, OEC9900 and/or OEC 9800 mobile C-arm, contact the local GE HealthCareService representative. 3.Ensure all potential users in their facility are made aware of this safety notification and the recommended actions. 4.Please complete and return the attached acknowledgement form [email protected]. GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to plan and schedule for the inspection and correction if needed. for any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 78 systems
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0705-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0703-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-18
Z-0704-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-18
Z-0705-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-18
Z-0706-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-18

Product code OXO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)