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Devices
Device Recall Airo
Model / Serial
Serial #s: 2251 (#1)*, 2324 (#2), 2328(#3), 2344 (#4), 2346 (#5), AIRO-0106, AIRO-0107*, AIRO-0108, AIRO-0110, AIRO-0111, AIRO-0112, AIRO-0113, AIRO-0114, AIRO-0115, AIRO-0116, AIRO-0117, AIRO-0118, AIRO-0119, AIRO-0120, AIRO-0122, and AIRO-0123. *Demo system
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
USA including AK, IL, WA, MA, NY, WV, NC, TX, CA, PA and Internationally to Germany, Netherlands, Belgium, Switzerland, Saudi Arabia, Egypt.
Product Description
Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
Manufacturer
Mobius Imaging, LLC
1 Event
Recall of Device Recall Airo
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Manufacturer
Mobius Imaging, LLC
Manufacturer Address
Mobius Imaging, LLC, 323 W Main St, Ayer MA 01432-1239
Manufacturer Parent Company (2017)
Mobius Imaging LLC
Source
USFDA
Language
English
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