Recall Z-1061-2015— Alltech Medical Systems America Inc
Class I · Terminated
Class I FDA medical device recall by Alltech Medical Systems America Inc, initiated 2015-01-09, terminated 2015-09-15. It names one FDA 510(k) clearance: K113511. Product: Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.. Reason: The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly..
- Recalling firm
- Alltech Medical Systems America Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-01-09
- Terminated
- 2015-09-15
- Firm location
- Solon, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
Reason for recall
The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.
Data sourced from openFDA. This site is unofficial and independent of the FDA.