GE SIGNA and DISCOVERY PET/MR Scanners Recalled for Elevated Acoustic Noise
GE Medical Systems is recalling SIGNA PET/MR and DISCOVERY PET/MR imaging systems because gradient coils can produce elevated acoustic noise during scanning under specific conditions.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard—elevated acoustic noise during scanning—is described in conditional terms without explicit patient safety risk framing, making this a voluntary precautionary equipment performance issue.
Plain-English summary
GE Medical Systems is recalling the SIGNA PET/MR and DISCOVERY PET/MR tomographic imaging systems. The gradient coils in these systems can produce elevated acoustic noise during scanning under specific conditions.
Two units have been identified in this recall, distributed worldwide to the United States and international locations including Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.
This is a Class II recall issued by the FDA. Healthcare facilities with affected equipment should contact GE Medical Systems for guidance and information regarding this issue.
The recalled product
- Product
- Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- Affected units
- 2
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 (4)
- 1) UDI/DI To be provided
- System ID 82427070262
- 2) UDI/DI To be provided
- System ID EX0133
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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