Airo® MobiCT-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00869346000200), received between Jan 11, 2019 and Aug 2, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

4 FDA recall records name this device's identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 4, 2025Open, Classified

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

   Z-1041-2026 · Root cause: Labeling Change Control · FDA record ↗

2. Dec 4, 2025Open, Classified

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

   Z-1040-2026 · Root cause: Labeling Change Control · FDA record ↗

3. Dec 7, 2022Open, Classified

   Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The firm will increase visibility of instructions for users to consider when transporting the unit in reverse by providing labels to be affixed onto the AIRO.

   Z-0957-2023 · Root cause: Use error · FDA record ↗

4. Nov 18, 2022Terminated

   Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems were bypassed to charge the batteries; the batteries in these units require replacing.

   Z-0344-2023 · Root cause: Other · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2023

  MACHINE WAS WARMED UP AND THE BED WAS FUNCTIONING. PATIENT WAS PUT TO SLEEP AND POSITIONED ON THE AIRO TABLE. HIP PINS WERE PLACED, CT WAS CALLED FOR THE SPIN. THE SCOUT WAS TAKEN FOLLOWED BY THE SCAN. AFTER THE SCAN WAS TAKEN, THE IMAGES WOULD NOT SEND AND THE AIRO JUST KEPT SPINNING AND SHUT OFF. STRYKER NAVIGATION REP CALLED THE AIRO REP AND WAS INSTRUCTED TO CALL THE STRYKER AIRO SUPPORT NUMBER. TROUBLE SHOOTING WAS UNSUCCESSFUL. CASE WAS CANCELED. NO INCISION WAS MADE. PATIENT WAS EXTUBATED AND SENT TO PACU. UPON INVESTIGATION FOUND BATTERY NUMBER 2 TO BE INOPERATIVE. THE DEVICE HAS A CONTROL PANEL WHICH INDICATES "POWER" AND "BATTERY CHARGING" ON THE LOWER LEFT OF THE SCREEN BUT IT CANNOT TELL THE CHARGE CAPACITY OF THE INDIVIDUAL BATTERIES TO KNOW THAT THEY WILL RETAIN THE CHARGE WHEN IT IS UNPLUGGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17452484 ↗
• InjurySep 2, 2022Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A CASE, THE AIRO TIPPED AND THE PATIENT SHIFTED OFF THE TABLE. THE PHYSICIAN'S ASSISTANT CAUGHT THE PATIENT'S HEAD AND DUE TO THE IMPACT FROM THE CATCH, THE PATIENT EXPERIENCED MILD LACERATIONS. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY AND THE PATIENT WILL BE RESCHEDULED FOR SURGERY.

  Patient problems: Fall; Laceration(s)

  MAUDE report 15347426 ↗
• InjuryJan 22, 2021Positioning Failure; Unintended Collision; Device Handling Problem; Positioning Failure; Unintended Collision; Device Handling Problem

  IT WAS REPORTED THAT, WHILE TRANSPORTING THE AIRO CT SCANNER, A NURSE EXPERIENCED A CRUSHING INJURY WHICH RESULTED IN THE AMPUTATION OF THEIR LEFT THUMB. THE AIRO SYSTEM WAS POSITIONED WITH THE PENDANT FACING THE OPERATING ROOM AND THE NURSE WAS HOLDING THE PENDANT HOLSTER TO MOVE THE AIRO SYSTEM BACKWARD WITH THE PENDANT IN THE HOLSTER DURING TRANSPORT. THERE WAS MATERIAL IN THE HALLWAY, MAKING IT DIFFICULT TO TURN THE MACHINE AROUND AND DRIVE FORWARD. THE NURSE HAD DIFFICULTY MANEUVERING THE AIRO AND CRUSHED THEIR HAND BETWEEN THE DEVICE AND THE OPERATING ROOM DOORWAY. THE NURSE WAS TAKEN TO THE EMERGENCY ROOM BY A COLLEAGUE AND RECEIVED TREATMENT FOR THEIR INJURY, RESULTING IN THE AMPUTATION OF THE LEFT THUMB.

  Patient problems: Crushing Injury

  MAUDE report 11214835 ↗
• MalfunctionJan 11, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  THE CUSTOMER REPORTED THAT DURING A DOUBLE-SIDED SI-SCREW-PLACEMENT WITH THE AIRO, THE ORIENTATION MARKERS ON THE IMAGE (FOOT/HEAD AND RIGHT/LEFT) WERE INCORRECT (REVERSED) FOR THE 2ND OF 3 SCANS. THE SURGEON WANTED TO OPTIMIZE ONE OF THE SCREWS, BUT BECAUSE OF THE WRONG ORIENTATION SHOWN ON IMAGE #2, THE SURGEON INITIALLY STARTED TO REMOVE THE INCORRECT SCREW. THEY REALIZED THE ERROR IMMEDIATELY AND PUT THE SCREW BACK IN THE SAME HOLE. THERE WAS NO ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8241927 ↗