Recall Z-0344-2023 ยท JAK System, X-Ray, Tomography, Computed
Mobius Imaging, LLC
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
| Date | Dec 6, 2022 (initiated Nov 18, 2022) |
| Status | Terminated |
| Reason | Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems were bypassed to charge the batteries; the batteries in these units require replacing. |
| Root cause | Other |
| Action | On November 18, 2022, the firm notified affected customers via Urgent Medical Device Correction letters. Customers were informed that a service representative will contact their facility to schedule a time to replace the batteries in the affected devices. The customer does not need to take additional action while waiting for the battery preplacement. If you have any questions or concerns regarding this update, please contact shirleytechnicalsupport@stryker.com or call Stryker Technical Support at 978 386 9619. |
| Quantity | 3 |
| Distribution | Domestic distribution to consignees in Colorado, Tennessee, and Utah. |
| 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 |