GE Healthcare MRI Systems Cryogen Ventilation System Defect Recall
GE Healthcare is recalling SIGNA Premier MRI systems due to a cryogen ventilation system that does not meet venting requirements. Approximately 17,228 affected devices were distributed worldwide.
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: FDA Class II recall addressing a cryogen ventilation system defect in medical imaging equipment. The hazard is potential with no reported injuries, placing this at High severity per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare is recalling 17,228 GE Healthcare MR superconducting magnets, which are components of the SIGNA Premier System magnetic resonance imaging systems. The recall addresses a cryogen ventilation system that does not meet required venting specifications.
Inadequate ventilation of cryogenic fluids in the affected systems poses a potential safety hazard to medical personnel and patients in MRI facilities. No injuries or illnesses have been reported in connection with this issue.
The affected systems were distributed nationwide in the United States, including Puerto Rico and the Virgin Islands, as well as internationally to over 80 countries. Healthcare facilities with affected SIGNA Premier Systems should contact GE Healthcare regarding inspection and remediation of the ventilation system defect.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- cryogen-ventilation-defect
- asphyxiation-risk
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)
- All systems.
Distribution
Distributed nationwide across the United States.
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