Recall Z-0715-2018— Mobius Imaging, LLC
Class II · Terminated
Class II FDA medical device recall by Mobius Imaging, LLC, initiated 2017-09-26, terminated 2018-08-16. 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: If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended or unpredictable device motion while the CT system is homing the axis at startup or preparing for a scan..
- Recalling firm
- Mobius Imaging, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-09-26
- Terminated
- 2018-08-16
- Firm location
- Shirley, MA, United States
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
If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended or unpredictable device motion while the CT system is homing the axis at startup or preparing for a scan.
Data sourced from openFDA. This site is unofficial and independent of the FDA.