Detachable 10in Pendant Upgrade component for the AIRO… recallZ-1041-2026 · Mobius Imaging, LLC · initiated Dec 4, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mobius Imaging, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
FDA root cause category: Labeling Change Control
What the company is doing
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.
Recall details
- Recall number
- Z-1041-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 4, 2025
- Posted by the FDA
- Jan 9, 2026
- Recalling firm
- Mobius Imaging, LLC
- Quantity
- 26 units
- Product code
- JAK
- FDA submissions
- K180393
- 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.
Product description
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Airo® MobiCT-32Mobius Imaging, LLC · System, X-Ray, Tomography, Computed4 recalls4 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98099).
- Z-1040-2026 · Open, ClassifiedDetachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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