Mobius Imaging, LLC recalls Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray S…

AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.

Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.

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.

• FDA enforcement recordOfficial FDA database entry for Z-1041-2026
• FDA 510(k) clearance · K180393The device's official FDA premarket clearance record
• FDA device classification · JAKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1750The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Mobius Imaging, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.