GE OEC Medical Systems, Inc Recall 95846
Description: 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.
GE OEC Medical Systems, Inc Recall 95846 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0703-2025 |
| Event ID | 95846 |
| Event Description | 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. |
| Product Type | Devices |
| 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 |
| Quantity | 84 systems |
| Recall Reason | 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. |
| Device Classification | 20241225 |
| Device Code Info | 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 |
| Center Classification Date | 20241218 |
| Recall Initiation Date | 20241121 |
| Recalling Firm | GE OEC Medical Systems, Inc |
| Initial Notification | Letter |
| Similar To |