Reported Sep 26, 2018 · Terminated
AIRO Mobile CT System Model # MobiCT-32
Mobius Imaging, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mobius Imaging, LLC · 2 Shaker Rd Ste F100 · Shirley, MA · 01464-2535
Is this the product you have?
- AIRO Mobile CT System Model # MobiCT-32
- Lot codes and dates
- Model # MobiCT-32
- Amount recalled
- 147
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Mobius Imaging, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.