GE Healthcare MRI systems recalled for cryogen ventilation defect
GE Healthcare is recalling certain MRI systems because the cryogen ventilation system does not meet venting requirements. The defect could affect safe operation of the MRI magnet.
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 an FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is described as a potential defect with no evidence of actual harm. Per the rubric, when no injuries are reported and the hazard is theoretical, the score is at most 3. Improper cryogen ventilation in MRI systems represents a risk-of-harm scenario, supporting a High severity rating.
Plain-English summary
GE Healthcare is recalling certain MRI systems. The affected systems include various SIGNA models (SIGNA HDx, SIGNA HDxt, SIGNA HDi, and SIGNA Vibrant systems) used for magnetic resonance imaging.
The recalled systems could potentially have a cryogen ventilation system that does not meet venting requirements.
Approximately 17,228 devices were distributed nationwide, including Puerto Rico and the Virgin Islands, as well as internationally to over 100 countries. Affected healthcare facilities should contact GE Healthcare for further information about this recall.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR System, GE 3.0T SIGNA HDxt MR System, 1.5T SIGNA HDxt, 3.0T SIGNA HDxt, 1.5T SIGNA HDxt Mobile, 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA…
- 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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