[pending] SIGNA Premier systems
Pending LLM rewrite. Source: FDA_DEVICE Z-1767-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.
The recalled product
- Product
- SIGNA Premier systems
- Manufacturer
- GE Healthcare LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI/GTIN: 00840682135269
- 00195278010797. System ID: 415353UMR2
- 415723SHMR19
- 413253MR3T
- 908725MR
- 609652MR3T
- M48823
- 7168453T
- 513584MR5
- 513636EASTMR
- 513636T1MR
- 605333MRPRM
- 832522CRMR1
- 703858PRE2
- 804675VA3T
- 082427110162
- 082427220143
- 082427020147
- 082427200242
- 082427160461
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- ModeratePhilips Allura X-ray Systems Deaeration Hose Degradation Recall
FDA (Devices) · 2026-05-27
- HighOncology Kit With Extension Sets May Leak During Infusion Therapy
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula vascular catheter sterile barrier breach
FDA (Devices) · 2026-05-27