Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
Reported: February 4, 2015 Initiated: December 8, 2014 #Z-1016-2015
Product Description
Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
Reason for Recall
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.
Details
- Recalling Firm
- Mobius Imaging, LLC
- Units Affected
- 21 devices distributed. 15 of these devices affected by the software v. 1.1.1+ patch
- Distribution
- USA including AK, IL, WA, MA, NY, WV, NC, TX, CA, PA and Internationally to Germany, Netherlands, Belgium, Switzerland, Saudi Arabia, Egypt.
- Location
- Ayer, MA
Frequently Asked Questions
What product was recalled? ▼
Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.. Recalled by Mobius Imaging, LLC. Units affected: 21 devices distributed. 15 of these devices affected by the software v. 1.1.1+ patch.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 4, 2015. Severity: Moderate. Recall number: Z-1016-2015.
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