AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The 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).
Reported: February 14, 2018 Initiated: July 28, 2017 #Z-0509-2018
Product Description
AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The 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).
Reason for Recall
Risk of unintended motion while the AIRO system is in transport mode.
Details
- Recalling Firm
- Brainlab AG
- Units Affected
- 102
- Distribution
- Worldwide Distribution - US Nationwide in the U.S. States: of AK, AZ, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, MT, MO, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, WA, and WV; and the countries of Argentina, Australia, Austria, Belgium, Canada, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Lithuania, Netherlands, Saudi Arabia, Spain, Switzerland, United Arab Emirates, and Uzbekistan.
- Location
- Munich, N/A
Frequently Asked Questions
What product was recalled? ▼
AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The 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).. Recalled by Brainlab AG. Units affected: 102.
Why was this product recalled? ▼
Risk of unintended motion while the AIRO system is in transport mode.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2018. Severity: Moderate. Recall number: Z-0509-2018.
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