Mobius AIRO Mobile CT System Recalled for Unintended Motion Risk
Mobius Imaging is recalling 105 AIRO Mobile CT Systems due to a risk of unintended device motion during startup or scan preparation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of unintended device motion, which poses a significant injury risk to patients and staff.
Plain-English summary
Mobius Imaging, LLC is recalling 105 units of the AIRO Mobile CT System, Model Number MobiCT-32. The recall is due to a potential defect in the tilt-drive motor, specifically an intermittent connection or broken encoder or sensor wire. This defect creates a risk of unintended or unpredictable device motion while the CT system is homing the axis at startup or preparing for a scan.
The affected devices 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 Mobius Imaging for further instructions on how to address this safety issue.
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
- Mobius Imaging, LLC
- Hazard
- Affected units
- 105
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Requested.
Distribution
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