Reported Mar 7, 2018 · Terminated
AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be used for X-ray computed…
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 NumberMobiCT-32
- Product UsageThe AIRO¿ is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg)
- Lot codes and dates
- Requested.
- Amount recalled
- 105
Where it was sold
Why it was recalled
If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended or unpredictable device motion while the CT system is homing the axis at startup or preparing for a scan.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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