GE SIGNA Architect AIR MRI Systems Recalled for Elevated Acoustic Noise
GE Medical Systems is recalling three SIGNA Architect AIR MRI systems due to gradient coils that can produce elevated acoustic noise during scanning. The units were distributed to the US and 12 countries worldwide.
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: This is a risk-of-harm medical device where potential for hearing damage exists but no injuries have been reported. Although classified as FDA Class II, the absence of hospitalization reports prevents a higher severity score, while the documented risk of acoustic-induced hearing damage elevates it above moderate precautionary recalls.
Plain-English summary
GE Medical Systems, LLC is recalling three SIGNA Architect AIR Nuclear Magnetic Resonance Imaging (MRI) systems due to a defect in their gradient coils. Under specific conditions during scanning, the affected systems can produce elevated acoustic noise.
Elevated acoustic noise during MRI scanning poses a risk of hearing damage to clinical staff and patients who may be exposed during repeated procedures. The gradient coil defect causes the systems to generate louder-than-normal acoustic output during operation.
The three affected systems have been distributed worldwide, including throughout the United States and to Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan. Each unit is identified by its unique UDI/DI code and System ID number.
Affected healthcare facilities should contact GE Medical Systems regarding corrective actions. Providers operating these systems should ensure appropriate hearing protection measures are in place for staff and patients during scanning procedures.
The recalled product
- Product
- SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Affected units
- 3
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 (01)00195278283481(11)231214(21)CNARC2300080TJ
- System ID 82427110161
- UDI/DI (01)00195278283481(11)230519(21)CNARC2300027TJ
- System ID 82427090471
- UDI/DI (01)00195278283481(11)231116(21)CNARC2300072TJ
- System ID 82427120353
- UDI/DI (01)00195278283481(11)230830(21)CNARC2300051TJ
- System ID 82427140303
- UDI/DI (01)00195278283481(11)230515(21)CNARC2300026TJ
- System ID 82427200210
- UDI/DI (01)00195278283481(11)230809(21)CNARC2300046TJ
- System ID 82427090487
- UDI/DI (01)00195278283481(11)230816(21)CNARC2300048TJ
- System ID 82427010214
- UDI/DI (01)00195278283481(11)230719(21)CNARC2300040TJ
- System ID 82427070331
- UDI/DI (01)00195278283481(11)230904(21)CNARC2300052TJ
- System ID 82427090477
- UDI/DI (01)00195278283481(11)231102(21)CNARC2300068TJ
- System ID 82427160409
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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