Recall Z-0957-2023 ยท JAK System, X-Ray, Tomography, Computed
Mobius Imaging, LLC
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
| Date | Jan 17, 2023 (initiated Dec 7, 2022) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Use error |
| Action | 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 de |
| Quantity | 303 |
| 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, Nethe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180393 | AIRO Computed Tomography (CT) X-ray System Mobius Imaging, LLC, Mar 15, 2018 |