CLASS II Device recall · Reported 14 Feb 2018 · FDA Enforcement Report
AIRO Mobile CT System recalled by Brainlab AG
Brainlab is recalling AIRO Mobile CT System, distributed nationwide in the US. The recall was initiated on 28 Jul 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0509-2018
- FDA event ID
- 79009
- Recalling firm
- Brainlab, Munich, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jul 2017
- FDA classified
- 2 Feb 2018
- Reported
- 14 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 28 Jul 2017 | Recall initiated by company | |
| 2 Feb 2018 | Classified by FDA | +189 days |
| 14 Feb 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Risk of unintended motion while the AIRO system is in transport mode.
Product as listed by the FDA
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).
Where it was distributed
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.
Nationwide AlaskaArizonaCaliforniaColoradoFloridaGeorgiaIllinoisKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMontanaNorth CarolinaNew JerseyNew YorkOhioPennsylvania
Questions about this recall
Why was it recalled?
Risk of unintended motion while the AIRO system is in transport mode.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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