Recall Z-1040-2026 ยท JAK System, X-Ray, Tomography, Computed
Mobius Imaging, LLC
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
| Date | Jan 9, 2026 (initiated Dec 4, 2025) |
| Status | Open, Classified |
| Reason | AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. |
| Root cause | Labeling Change Control |
| Action | An URGENT MEDICAL DEVICE CORRECTION notice dated 12/4/25 instructs consignees to ensure the following mitigations are in place while the correction is deployed: the hand position warnings as indicated in the IFU, train operators, the AIRO is accessible through a physical key switch and password protected log in screen, and the Backing Up System Warning label is affixed on to the gantry of affected devices. Stryker will correct devices during an upcoming service visit. Consignees are to inform users of devices of this recall by sharing the recall notice, immediately check stock areas and operat |
| Quantity | 101 units |
| Distribution | US Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, IL, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, RI, SC, TN, TX, UT, VA, WI. |
| 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 |