Brainlab AIRO Mobile CT System Recalled for Unintended Motion Risk
Brainlab AG is recalling 102 AIRO Mobile CT Systems due to a risk of unintended motion while the system is in transport mode.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (unintended motion of a mobile medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Brainlab AG is recalling 102 units of the AIRO Mobile CT System, Model Number MobiCT-32. The recall is due to a risk of unintended motion while the system is in transport mode.
The affected units were distributed worldwide, including in the United States and various international markets. The AIRO system is intended 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).
Healthcare facilities and users should contact Brainlab AG for instructions on how to address the defect. The recall covers all units released since April 2014.
The recalled product
- Product
- 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).
- Manufacturer
- Brainlab AG
- Hazard
- Affected units
- 102
Distribution
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