Z-0509-2018Class II

AIRO Mobile CT System, Model Number: MobiCT-32

Name: Z-0509-2018 AIRO Mobile CT System, Model Number: MobiCT-32
Creator: Brainlab AG
Published: 2017-07-28
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2017-07-28 / Terminated / root cause: design

FDA source

Brainlab AG began a recall of AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can... on 2017-07-28. FDA classified it as Class II and gives the reason as "Risk of unintended motion while the AIRO system is in transport mode". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0509-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-28
Posted: 2018-02-03
Terminated: 2018-07-25
Recalling firm: Brainlab, Inc.
Product: AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Risk of unintended motion while the AIRO system is in transport mode.
Root cause tag: design
FDA root cause: Component design/selection
Action: AIRO customers were issued Field Safety Notices dated June 29, 2017. The letter identified the affected product, problem and actions to be taken. A warning label was provided to be placed on the system. For questions contact your local Brainlab Customer Support Representative.
Quantity in commerce: 102
Distribution: Worldwide Distribution - US Nationwide in the U.S. States: of AK, AZ, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, MT, MO, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, WA, and WV; and the countries of Argentina, Australia, Austria, Belgium, Canada, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Lithuania, Netherlands, Saudi Arabia, Spain, Switzerland, United Arab Emirates, and Uzbekistan.
Product codes and lots: All units released since April 2014. Serial numbers: AIRO-2251 AIRO-2328 AIRO-2344 AIRO-2324 AIRO-2346 AIRO-0106 AIRO-0107-R AIRO-0108 AIRO-0109 AIRO-0110 AIRO-0111 AIRO-0112 AIRO-0113 AIRO-0114 AIRO-0115 AIRO-0116 AIRO-0117 AIRO-0118 AIRO-0119 AIRO-0120 AIRO-0121 AIRO-0122 AIRO-0124 AIRO-0125 AIRO-0126 AIRO-0127 AIRO-0128 AIRO-0129 AIRO-0130 AIRO-0131 AIRO-0132 AIRO-0133 AIRO-0134 AIRO-0136 AIRO-0137 AIRO-0138 AIRO-0139 AIRO-0140 AIRO-0141 AIRO-0142 AIRO-0143 AIRO-0144 AIRO-0145 AIRO-0146 AIRO-0148 AIRO-0149 AIRO-0151 AIRO-0152 AIRO-0153 AIRO-0154 AIRO-0155 AIRO-0156 AIRO-0157 AIRO-0158 AIRO-0159 AIRO-0160 AIRO-0161 AIRO-0162 AIRO-0163 AIRO-0164 AIRO-0165 AIRO-0166 AIRO-0167 AIRO-0168 AIRO-0170 AIRO-0172 AIRO-0174 AIRO-0175 AIRO-0176 AIRO-0177 AIRO-0178 AIRO-0180 AIRO-0181 AIRO-0182 AIRO-0184 AIRO-0186 AIRO-0187 AIRO-0188 AIRO-0189 AIRO-0190 AIRO-0191 AIRO-0192 AIRO-0193 AIRO-0194 AIRO-0195 AIRO-0196 AIRO-0197 AIRO-0198 AIRO-0199 AIRO-0200 AIRO-0201 AIRO-0202 AIRO-0203 AIRO-0204 AIRO-0205 AIRO-0206 AIRO-0207 AIRO-0211 AIRO-0212 AIRO-0213 AIRO-0214 AIRO-0216

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0509-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0509-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-02

Product code JAK

K160126Class IIAIRO Computed Tomography (CT) X-ray SystemMobius Imaging / cleared 2016-04-19

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)