Z-1041-2026Class II

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

Name: Z-1041-2026 Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System
Creator: Mobius Imaging, LLC
Published: 2025-12-04
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2025-12-04 / Open, Classified / root cause: labeling and UDI

FDA source

Mobius Imaging, LLC began a recall of Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System on 2025-12-04. FDA classified it as Class II and gives the reason as "AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1041-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-04
Posted: 2026-01-09
Recalling firm: Brainlab, Inc.
Product: Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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.
Quantity in commerce: 26 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1041-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1040-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-09
Z-1041-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-09

Product code JAK

K180393Class IIAIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC / cleared 2018-03-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)