OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy…
Medical device recall Z-0705-2025. Published in FDA’s Enforcement Report on Dec 25, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 25, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 45 states named in where it went
- 78 systems how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
78 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,996 characters
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…
FDA’s list runs to 5,189 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
The states and territories these words name
45 states and territories.
Every one of them
- Alaska
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Florida
- Georgia
- Guam
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 21, 2024.
- FDA classified it on Dec 18, 2024.
- FDA’s Enforcement Report published it on Dec 25, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE OEC Medical Systems, Inc, of Salt Lake City, UT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,189 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.