Alltech Medical Systems Recalls Two MRI Systems Due to Safety Feature Failure
Alltech Medical Systems America Inc is recalling two Echostar Spica 1.5T MRI systems because the emergency magnetic field lowering feature may not work correctly.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly."
Plain-English summary
Alltech Medical Systems America Inc is recalling two Echostar Spica 1.5T MRI systems. These devices are used for magnetic resonance imaging of the body. The recall involves two specific units with serial numbers D-ESP-1001 and D-ESP-1003.
The recall is being issued because the MRI system's safety feature, which is designed to lower the magnetic field in emergency situations, may not work correctly. This defect could compromise the safety of the device during emergency operations.
The affected units were distributed in the state of Maryland. Consumers and healthcare facilities with these specific serial numbers should contact the recalling firm for further instructions on how to address the safety issue.
The recalled product
- Product
- Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
- Manufacturer
- Alltech Medical Systems America Inc
- 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 (1)
- Serial numbers: D-ESP-1001 and D-ESP-1003
Distribution
Distributed in 1 state:
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