MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
- Company
- Mobius Imaging, Llc
- Recall Initiated
- December 7, 2022
- Posted
- January 17, 2023
- Recall Number
- Z-0957-2023
- Quantity
- 303
- Firm Location
- Shirley, MA
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Chinese Taipei, Denmark, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Korea, Republic of Kuwait, Lithuania, Malaysia, Mexico, Morocco, Nepal, Netherlands, Norway, Pakistan, Poland, Russian Federation, Saudi Arabia, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom, Viet Nam.
Lot / Code Info
UDI-DI: 00869346000200 ALL Serial numbers
Root Cause
Use error
Action Taken
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.