GE Healthcare 1.5T SIGNA MRI systems recalled for ventilation defect
GE Healthcare is recalling 17,228 of its 1.5T SIGNA HDe MR imaging systems because the cryogenic ventilation system does not meet required venting standards.
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: This is a risk-of-harm medical device (MRI cryogenic system) where the identified defect in ventilation could pose safety risks. No illnesses, injuries, or hospitalizations have been reported, placing this recall in the 'High' category for risk-of-harm products without reported injury.
Plain-English summary
GE Healthcare is recalling its 1.5T SIGNA HDe MR imaging systems, specifically the superconducting magnet components. The recall affects approximately 17,228 devices distributed nationwide throughout the United States, Puerto Rico, and the Virgin Islands, as well as to government and military facilities and more than 80 countries worldwide.
The recall was initiated because the cryogenic ventilation system in these magnetic resonance systems does not meet the required venting specifications. Proper ventilation of the cryogenic system is critical to safe operation of the imaging equipment.
Healthcare facilities, imaging centers, and other institutions that operate or maintain these systems may be affected by this recall.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 17,228
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
Part of a larger recall action
This product is one of 32 recalled by GE Healthcare, 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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