Device product
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Z-1041-2026
Product summary
- Event
- Event 98099
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 26 units
- Official record key
device-enforcement:Z-1041-2026
Official wording
Reason: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Code information: 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.
Distribution pattern: 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.
Derived failure modes
-
Unknown
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.