GE SIGNA Premier MRI magnets may have ferrous fittings fitted
SIGNA Premier MRI systems are being recalled because they may have been built or serviced with ferrous steel fittings instead of non-ferrous brass on the magnet rear.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: ferrous fittings could be pulled by the magnetic field during service and injure personnel, and no injuries are stated.
Plain-English summary
SIGNA Premier systems are being recalled. About 41 units were distributed across nine US states and Puerto Rico and to twelve other countries. The FDA has classified this recall as Class II.
Whole-body MR scanners, used to produce images of the inside of the human body to aid diagnosis of disease, may have been manufactured or serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear. If the system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings, potentially resulting in personnel injury.
Affected systems are identified in the FDA enforcement record.
Facilities can identify affected systems by the product details above, and may contact the recalling firm for further information.
The recalled product
- Product
- SIGNA Premier systems
- Manufacturer
- GE Healthcare LLC
- Category
- Medical Device — MRI
- Affected units
- 41
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
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