Mobius Imaging, LLC MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
Brand
Mobius Imaging, LLC
Lot Codes / Batch Numbers
UDI-DI: 00869346000200 ALL Serial numbers
Products Sold
UDI-DI: 00869346000200 ALL Serial numbers
Mobius Imaging, LLC is recalling MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system. due to Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The fir. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The firm will increase visibility of instructions for users to consider when transporting the unit in reverse by providing labels to be affixed onto the AIRO.
Recommended Action
Per FDA guidance
On December 7, 2022, the firm notified customers via Urgent Medical Device Correction letters. Customers were informed that the firm would add additional warning labels to the Airo to increase visibility of instructions for users to consider when transporting an Airo TruCT unit in reverse. A service representative will contact your facility once labels are available (anticipated February 2023) to schedule a time to affix the labeling to your Airo TruCT unit. In the interim, please ensure all Airo TruCT users and other relevant personnel in your facilities are informed of this issue. If the devices have been distributed to other organizations, inform Stryker so that they may inform personnel at the new locations appropriately. If you have any questions or concerns regarding this notification, please contact shirleytechnicalsupport@stryker.com or call Stryker Technical Support at 978 386 9619.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026