| | Class 2 Device Recall OEC 3D |  |
| Date Initiated by Firm | November 21, 2024 |
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| Date Posted | December 18, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0703-2025 |
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| Recall Event ID |
95846 |
| 510(K)Number | K203346 K233669 |
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| Product Classification |
Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
|
| Product | 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. |
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| 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
|
Recalling Firm/
Manufacturer |
GE OEC Medical Systems, Inc
384 N Wright Brothers Dr
Salt Lake City UT 84116-2862
|
| For Additional Information Contact | GE HealthCare Service
800-437-1171 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Process control |
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| 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 torecall.15150@gehealthcare.com.
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. |
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| Quantity in Commerce | 84 systems |
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| 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 |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = OXO
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