Mobile CT Scanner Injury Risk During Reverse Transport
Mobius Imaging recalls the MobiCT-32 AIRO Mobile CT Scanner after one untrained user was injured while moving the unit in reverse. The manufacturer will add warning labels to improve instructions for safe reverse transport.
What this means for you
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: This is a Class II medical device recall with one documented injury report. The injury occurred during product operation (reverse transport), but lacks specificity regarding severity or hospitalization. The remedy is informational (labels), placing this at High rather than Severe severity.
Plain-English summary
The MobiCT-32 AIRO Mobile CT Scanner, a mobile computed tomography system manufactured by Mobius Imaging, LLC, is being recalled. The recall was initiated following one report of an injury to an untrained user that occurred while moving the unit in reverse.
The affected equipment includes 303 units distributed worldwide, including throughout the United States and to countries including Canada, United Kingdom, Australia, Germany, France, Japan, and others. All serial numbers of the product (UDI-DI: 00869346000200) are included in the recall.
In response to the incident, the manufacturer will increase visibility of transport instructions by providing labels to be affixed to the units. These labels are intended to communicate safety information to users when transporting the equipment in reverse.
The recalled product
- Product
- MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
- Manufacturer
- Mobius Imaging, LLC
- Hazard
- transport-injury
- insufficient-labeling
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)
- UDI-DI: 00869346000200 ALL Serial numbers
Distribution
Distributed nationwide across the United States.
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