Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures.
Why it was 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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
Product Name: OEC 3D GTIN code: 00195278096944 Lot/Serial Numbers / UDI codes: FBMHDX00436 (01)00195278096944(11)240800(21)FBMHDX00436 FBMHDX00352 (01)00195278096944(11)240500(21)FBMHDX00352 FBMHDX00455 (01)00195278096944(11)240900(21)FBMHDX00455 FBMHDX00384 (01)00195278096944(11)240600(21)FBMHDX00384 FBMHDX00434 (01)00195278096944(11)240900(21)FBMHDX00434 FBMHDX00443 (01)00195278096944(11)240900(21)FBMHDX00443 FBMHDX00407 (01)00195278096944(11)240700(21)FBMHDX00407 FBMHDX00363 (01)00195278096944(11)240500(21)FBMHDX00363 FBMHDX00424 (01)00195278096944(11)240800(21)FBMHDX00424 FBMHDX00442 (01)00195278096944(11)240900(21)FBMHDX00442 FBMHDX00321 (01)00195278096944(11)240300(21)FBMHDX00321 FBMHDX00387 (01)00195278096944(11)240600(21)FBMHDX00387 FBMHDX00339 (01)00195278096944(11)240400(21)FBMHDX00339 FBMHDX00448 (01)00195278096944(11)240900(21)FBMHDX00448 FBMHDX00383 (01)00195278096944(11)240600(21)FBMHDX00383 FBMHDX00437 (01)00195278096944(11)240900(21)FBMHDX00437 FBMHDX00362 (01)00195278096944(11)240500(21)FBMHDX00362 FBMHDX00394 (01)00195278096944(11)240600(21)FBMHDX00394 FBMHDX00397 (01)00195278096944(11)240700(21)FBMHDX00397 FBMHDX00395 (01)00195278096944(11)240700(21)FBMHDX00395 FBMHDX00355 (01)00195278096944(11)240500(21)FBMHDX00355 FBMHDX00374 (01)00195278096944(11)240600(21)FBMHDX00374 FBMHDX00451 (01)00195278096944(11)240900(21)FBMHDX00451 FBMHDX00368 (01)00195278096944(11)240500(21)FBMHDX00368 FBMHDX00457 (01)00195278096944(11)241000(21)FBMHDX00457 FBMHDX00440 (01)00195278096944(11)240900(21)FBMHDX00440 FBMHDX00419 (01)00195278096944(11)240800(21)FBMHDX00419 FBMHDX00421 (01)00195278096944(11)240800(21)FBMHDX00421 FBMHDX00427 (01)00195278096944(11)240800(21)FBMHDX00427 FBMHDX00459 (01)00195278096944(11)240900(21)FBMHDX00459 FBMHDX00378 (01)00195278096944(11)240600(21)FBMHDX00378 FBMHDX00345 (01)00195278096944(11)240400(21)FBMHDX00345 FBMHDX00458 (01)00195278096944(11)240900(21)FBMHDX00458 FBMHDX00425 (01)00195278096944(11)240800(21)FBMHDX00425 FBMHDX00366 (01)00195278096944(11)240500(21)FBMHDX00366 FBMHDX00480 (01)00195278096944(11)241100(21)FBMHDX00480 FBMHDX00418 (01)00195278096944(11)240800(21)FBMHDX00418 FBMHDX00454 (01)00195278096944(11)240900(21)FBMHDX00454 FBMHDX00188 (01)00195278096944(11)230300(21)FBMHDX00188 FBMHDX00403 (01)00195278096944(11)240700(21)FBMHDX00403 FBMHDX00452 (01)00195278096944(11)240900(21)FBMHDX00452 FBMHDX00386 (01)00195278096944(11)240600(21)FBMHDX00386 FBMHDX00343 (01)00195278096944(11)240400(21)FBMHDX00343 FBMHDX00369 (01)00195278096944(11)240500(21)FBMHDX00369 FBMHDX00464 (01)00195278096944(11)240900(21)FBMHDX00464 FBMHDX00413 (01)00195278096944(11)240800(21)FBMHDX00413 FBMHDX00346 (01)00195278096944(11)240400(21)FBMHDX00346 FBMHDX00388 (01)00195278096944(11)240600(21)FBMHDX00388 FBMHDX00389 (01)00195278096944(11)240600(21)FBMHDX00389 FBMHDX00406 (01)00195278096944(11)240700(21)FBMHDX00406 FBMHDX00416 (01)00195278096944(11)240800(21)FBMHDX00416 FBMHDX00453 (01)00195278096944(11)240900(21)FBMHDX00453 FBMHDX00399 (01)00195278096944(11)240700(21)FBMHDX00399 FBMHDX00401 (01)00195278096944(11)240700(21)FBMHDX00401 FBMHDX00428 (01)00195278096944(11)240800(21)FBMHDX00428 FBMHDX00380 (01)00195278096944(11)240600(21)FBMHDX00380 FBMHDX00371 (01)00195278096944(11)240600(21)FBMHDX00371 FBMHDX00392 (01)00195278096944(11)240600(21)FBMHDX00392 FBMHDX00344 (01)00195278096944(11)240400(21)FBMHDX00344 FBMHDX00404 (01)00195278096944(11)240700(21)FBMHDX00404 FBMHDX00356 (01)00195278096944(11)240500(21)FBMHDX00356 FBMHDX00376 (01)00195278096944(11)240600(21)FBMHDX00376 FBMHDX00470 (01)00195278096944(11)241000(21)FBMHDX00470 FBMHDX00353 (01)00195278096944(11)240500(21)FBMHDX00353 FBMHDX00359 (01)00195278096944(11)240500(21)FBMHDX00359 FBMHDX00391 (01)00195278096944(11)240600(21)FBMHDX00391 FBMHDX00460 (01)00195278096944(11)240900(21)FBMHDX00460 FBMHDX00410 (01)00840682121729(11)240700(21)FBMHDX00410 FBMHDX00379 (01)00195278096944(11)240600(21)FBMHDX00379 FBMHDX00390 (01)00195278096944(11)240600(21)FBMHDX00390 FBMHDX00449 (01)00195278096944(11)240900(21)FBMHDX00449 FBMHDX00372 (01)00195278096944(11)240600(21)FBMHDX00372 FBMHDX00377 (01)00195278096944(11)240600(21)FBMHDX00377 FBMHDX00462 (01)00195278096944(11)240900(21)FBMHDX00462 FBMHDX00338 (01)00195278096944(11)240400(21)FBMHDX00338 FBMHDX00423 (01)00195278096944(11)240800(21)FBMHDX00423 FBMHDX00420 (01)00195278096944(11)240800(21)FBMHDX00420 FBMHDX00438 (01)00195278096944(11)240900(21)FBMHDX00438 FBMHDX00432 (01)00195278096944(11)240900(21)FBMHDX00432 FBMHDX00373 (01)00195278096944(11)240600(21)FBMHDX00373 FBMHDX00367 (01)00195278096944(11)240500(21)FBMHDX00367 FBMHDX00446 (01)00195278096944(11)240900(21)FBMHDX00446 FBMHDX00370 (01)00195278096944(11)240600(21)FBMHDX00370 FBMHDX00429 (01)00195278096944(11)240800(21)FBMHDX00429
Recall status
Ongoing — the recall is still being carried out.
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
Recall record
- Recalling firm
- GE OEC Medical Systems, Inc
- Product type
- Devices
- Recall number
- Z-0703-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Salt Lake City, UT
- Recall initiated
- 2024-11-21
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-0703-2025 · Source: openFDA enforcement.