The Recall Desk
HighFDA (Devices)·Z-1061-2015·Announced 2015-02-25

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.

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 medical device with a safety feature that may not function correctly, representing a risk-of-harm product where injury has not yet been reported, which aligns with the High severity criteria.

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:

Related recalls

Same hazard · safety feature failure

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