Brainlab AG: Medical Device Recall in 2018 - (Recall #: Z-0509-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: July 28, 2017

Date Posted: February 14, 2018

Recall Number: Z-0509-2018

Event ID: 79009

Reason for Recall:

Risk of unintended motion while the AIRO system is in transport mode.

Status: Terminated

Product Quantity: 102

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated