MRI Systems Allow Unsafe Scan Resumption Exceeding SAR Safety Limits
GE Healthcare MRI systems may incorrectly resume scans after power loss when tissue heating rates exceed safe limits, risking excessive heating if patients contact conductive materials or have implants.
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: The recall involves a software defect in an FDA Class II medical device that creates a risk of excessive tissue heating from MRI radiofrequency energy. No illnesses or injuries have been reported, and the hazard is theoretical/potential in nature. This qualifies as a risk-of-harm product where injury has not yet been reported, placing it in the High (Score 3) category per the rubric.
Plain-English summary
GE Healthcare SIGNA Creator, SIGNA Explorer, and NMRI systems are subject to a recall affecting approximately 2,538 units distributed domestically and internationally. The issue involves a software defect in the user interface that can allow scans to resume following a Power Monitor trip when the 6-minute average SAR (Specific Absorption Rate) exceeds the safe limits shown on the SAR Display.
The problem is that the user interface may incorrectly enable a scan to proceed earlier than intended. When an operator resumes a scan under these conditions, the system can result in potential excessive tissue heating, particularly when patients are in contact with conductive materials or have implants.
Owners and operators of affected systems should contact GE Healthcare regarding this recall for corrective actions and further guidance.
The recalled product
- Product
- SIGNA Creator, SIGNA Explorer, NMRI systems
- Manufacturer
- GE Healthcare (China) Co., Ltd.
- Affected units
- 2,538
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 (1)
- 1. Creator A. UDI-DI 00195278577221
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by GE Healthcare (China) Co., Ltd. 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.
See all 5 products in this recall →Related recalls
Same manufacturer · GE Healthcare (China) Co., Ltd.
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