Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall AIRO Computed Tomography (CT) Xray System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall AIRO Computed Tomography (CT) Xray Systemsee related information
Date Initiated by FirmDecember 04, 2025
Date PostedJanuary 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1041-2026
Recall Event ID 98099
510(K)NumberK180393 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductDetachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
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.
Recalling Firm/
Manufacturer		 Mobius Imaging, LLC
2 Shaker Rd Ste F100
Shirley MA 01464-2535
Manufacturer Reason
for Recall		AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
FDA Determined
Cause 2		Labeling Change Control
ActionAn 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.
Quantity in Commerce26 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JAK
-
-