Reported Feb 4, 2015 · Terminated
Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
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 · 323 W Main St · Ayer, MA · 01432-1239
Is this the product you have?
- Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
- Lot codes and dates
Serial #s: 2251 (#1)*2324 (#2)2328(#3)2344 (#4)2346 (#5)AIRO-0106AIRO-0107*AIRO-0108AIRO-0110AIRO-0111AIRO-0112AIRO-0113AIRO-0114AIRO-0115AIRO-0116AIRO-0117AIRO-0118AIRO-0119AIRO-0120AIRO-0122and AIRO-0123. *Demo system
- Amount recalled
- 21 devices distributed. 15 of these devices affected by the software v. 1.1.1+ patch
Where it was sold
Why it was recalled
There is a risk that during the transfer of an image and navigation data to the Brainlab Curve Image Guided Surgery Navigation System after a CT scan, an error may occur, causing either no navigation data or incorrect navigation data being transferred to the curve.
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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