GE Healthcare MRI superconducting magnets recalled for improper cryogen venting
GE Healthcare has recalled SIGNA Pioneer MRI systems due to potential cryogen ventilation defects that do not meet safety requirements. Approximately 17,228 devices are affected nationwide and internationally.
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 Class II recall concerns a potential defect in the cryogen ventilation system of a medical device component. No illnesses or injuries have been reported. Per the severity rubric, this qualifies as a risk-of-harm product without documented injury, warranting a High severity score.
Plain-English summary
GE Healthcare, LLC is recalling MR superconducting magnets used in the SIGNA Pioneer System, a nuclear magnetic resonance (MRI) imaging system. The recall affects approximately 17,228 devices and is classified as a Class II recall by the FDA.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. These systems are found in the superconducting magnets component of the SIGNA Pioneer System.
The affected devices were distributed nationwide in the United States, including Puerto Rico and the Virgin Islands, as well as to government and military facilities. International distribution extended to more than 100 countries.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer 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.
See all 32 products in this recall →Related recalls
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