SIGNA Premier MRI scanner recalled for elevated acoustic noise hazard
GE Healthcare's SIGNA Premier MRI scanner is being recalled because under rare conditions, the gradient coils can produce elevated acoustic noise that could potentially cause hearing loss with prolonged exposure.
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 source describes a potential health hazard (hearing loss from acoustic noise) with no reported illnesses or injuries. Per the rubric, theoretical hazards without documented injuries are assigned a maximum severity of 3 (High).
Plain-English summary
GE Healthcare, LLC has recalled 52 units of the SIGNA Premier magnetic resonance (MRI) scanner, model 5748519. The recall addresses a potential hazard with the scanner's gradient coils.
Under rare conditions, the gradient coils can produce elevated acoustic noise during scanning. Prolonged exposure to this elevated acoustic noise could potentially lead to hearing loss in users or clinical staff.
The affected units were distributed worldwide, including throughout several U.S. states (Alabama, Arizona, California, Michigan, Minnesota, New York, and Wisconsin) and internationally in China, France, Hong Kong, India, Italy, Japan, Korea, Kuwait, Norway, Oman, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, and the United Kingdom.
The recalled product
- Product
- SIGNA Premier magnetic resonance scanner, model 5748519.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 52
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)
- SIGNA Premier GTINs: 00840682135269 and 00195278010797
Distribution
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