AIRO Mobile CT System Model # MobiCT-32
Reported: September 26, 2018 Initiated: August 1, 2018 #Z-2991-2018
Product Description
AIRO Mobile CT System Model # MobiCT-32
Reason for Recall
The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan is completed.
Details
- Recalling Firm
- Mobius Imaging, LLC
- Units Affected
- 147
- Distribution
- US and foreign distribution.
- Location
- Shirley, MA
Frequently Asked Questions
What product was recalled? ▼
AIRO Mobile CT System Model # MobiCT-32. Recalled by Mobius Imaging, LLC. Units affected: 147.
Why was this product recalled? ▼
The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan is completed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 26, 2018. Severity: Moderate. Recall number: Z-2991-2018.
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