OEC 3D
Medical device recall Z-1820-2025. Published in FDA’s Enforcement Report on Jun 18, 2025.
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 Jun 18, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- Total for both products: 3472 (2,919 US; 553 OUS) 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?
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
OEC 3D
Total for both products: 3472 (2,919 US; 553 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Two populations are potentially affected by this notification. 1. Listed in Appendix A - OEC Elite Mobile C-arm Systems (GTIN: 00001234567895) and OEC 3D Mobile C-arm Systems (GTIN: 00195278096944) that potentially have an X-ray field size…
Every code shown here, 1,996 characters
Two populations are potentially affected by this notification. 1. Listed in Appendix A - OEC Elite Mobile C-arm Systems (GTIN: 00001234567895) and OEC 3D Mobile C-arm Systems (GTIN: 00195278096944) that potentially have an X-ray field size greater than the 4% SID limit and do not contain the acceptance limit for the X-ray field size measurement in the System Service Manual. 2. Systems NOT listed in Appendix A - OEC Elite Mobile C-arm Systems (GTIN: 00001234567895) and OEC 3D Mobile C-arm Systems (GTIN: 00195278096944) that are within the allowed SID limit. However, the acceptance limit for the X-ray field size measurement is not stated in the System Service Manual. Appendix A Serial Numbers FAHXTX00002 FAHXTX00005 FAHXTX00014 FAHXTX00018 FAHXTX00019 FAHXTX00020 FAHXTX00024 FAHXTX00028 FAHXTX00034 FAHXTX00037 FAHXTX00043 FAHXTX00052 FAHXTX00063 FAHXTX00066 FAHXTX00068 FAHXTX00070 FAHXTX00075 FAHXTX00078 FAHXTX00079 FAHXTX00080 FAHXTX00081 FAHXTX00083 FAHXTX00092 FAHXTX00093 FAHXTX00097 FAHXTX00110 FAHXTX00111 FAHXTX00112 FAHXTX00114 FAHXTX00115 FAHXTX00116 FAHXTX00117 FAHXTX00118 FAHXTX00119 FAHXTX00120 FAHXTX00121 FAHXTX00122 FAHXTX00124 FAHXTX00125 FAHXTX00135 FAHXTX00137 FAHXTX00138 FAHXTX00151 FAHXTX00152 FAHXTX00155 FAHXTX00156 FAHXTX00162 FAHXTX00163 FAHXTX00166 FAHXTX00170 FAHXTX00171 FAHXTX00177 FAHXTX00178 FAHXTX00188 FAHXTX00192 FAHXTX00193 FAHXTX00202 FAHXTX00204 FAHXTX00211 FAHXTX00212 FAHXTX00217 FAHXTX00219 FAHXTX00220 FAHXTX00221 FAHXTX00222 FAHXTX00223 FAHXTX00224 FAHXTX00226 FAHXTX00227 FAHXTX00229 FAHXTX00230 FAHXTX00236 FAHXTX00240 FAHXTX00244 FAHXTX00261 FAHXTX00265 FAHXTX00266 FAHXTX00269 FAHXTX00271 FAHXTX00272 FAHXTX00273 FAHXTX00274 FAHXTX00280 FAHXTX00283 FAHXTX00284 FAHXTX00296 FAHXTX00299 FAHXTX00300 FAHXTX00304 FAHXTX00305 FAHXTX00308 FAHXTX00312 FAHXTX00313 FAHXTX00320 FAHXTX00323 FAHXTX00325 FAHXTX00332 FAHXTX00340 FAHXTX00342 FAHXTX00343 FAHXTX00352 FAHXTX00353 FAHXTX00354 FAHXTX00357 FAHXTX00358 FAHXTX00359 FAHXTX00360 FAHXTX00363…
FDA’s list runs to 41,080 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.
US and OUS
These words name no state.
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 Mar 21, 2025.
- FDA classified it on Jun 9, 2025.
- FDA’s Enforcement Report published it on Jun 18, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Medical Systems, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: FDA Mandated.
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 41,080 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
-
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.