Recall Z-1041-2026
Mobius Imaging, LLC · initiated December 4, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Codes / lots: Part No. MI-70-0128; UDI: (01) 00869346000200 (11)230920 (21) AIRO-XXXX; Serial No. 2232206183, 2232206193, 2232206203, 2232206213, 2232206223, 2232206233, 2235522143, 2235522153, 2235522163, 2236339153, 2236339163, 2236339173, 2236339183, 2303429483, 2303429503, 2313925663, 2313925673, 2316030773, 2316030783, 2316703503, 2316703523, 2317415473, 2320006923, 2320006933, 2323513413, 70-0128-13904392.
Reason for recall
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
FDA-determined cause: Labeling Change Control
Action taken
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 operating rooms to identify affected devices, and inform all users of the potential harms and their risk mitigations. Consignees with any questions are to contact their local sales office or Stryker Representative.
Details
- Recall number
- Z-1041-2026
- Initiated
- December 4, 2025
- Posted by FDA
- January 9, 2026
- Product code
- JAK – System, X-Ray, Tomography, Computed
- Quantity
- 26 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.
- Recalling firm
- Mobius Imaging, LLC, Shirley, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1040-2026 Class II | Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray…AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. | 12/04/2025Open, Classified |