Elekta Unity MRI Speakers May Become Dislodged and Enter Bore
Elekta Limited is recalling two Elekta Unity MRI systems because speakers can become dislodged and be pulled into the bore in rare circumstances.
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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Elekta Limited is recalling two units of the Elekta Unity MRI system. The recall affects units with serial number 1536549. These systems were distributed in Texas, Wisconsin, Germany, Denmark, the Netherlands, and the United Kingdom.
The recall is due to a risk that speakers can become dislodged and be pulled into the bore. This can occur in rare circumstances due to factors such as inadequate hospital facility maintenance, water leakage, or the weakening of speaker fixings over the lifetime of the system.
Hospitals and facilities with these specific units should contact Elekta Limited for further instructions on how to address the issue.
The recalled product
- Product
- Elekta Unity
- Manufacturer
- Elekta Limited
- Category
- Medical Device — MRI System
- Hazard
- Affected units
- 2
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 (2)
- Serial Numbers: 1536549
- 1536549
Distribution
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