Recall Z-0509-2018— Brainlab AG
Class II · Terminated
Class II FDA medical device recall by Brainlab AG, initiated 2017-07-28, terminated 2018-07-25. It names one FDA 510(k) clearance: K160126. 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).. Reason: Risk of unintended motion while the AIRO system is in transport mode..
- Recalling firm
- Brainlab AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-28
- Terminated
- 2018-07-25
- Firm location
- Munich, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.