Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
FDA device recall Z-1040-2026 · posted 2026-01-09 · Open, Classified
Recall details
- Recalling firm
- Mobius Imaging, LLC
- Reason for recall
- AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
- 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.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- JAK
- Quantity affected
- 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.
- Date initiated
- 2025-12-04
- Date posted
- 2026-01-09
- Location
- Shirley, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AIRO Computed Tomography (CT) X-ray System (K180393) | Mobius Imaging, LLC | 2018-03-15 |