| Class 2 Device Recall Mobius Imaging AIRO CT | |
Date Initiated by Firm | July 28, 2017 |
Create Date | February 03, 2018 |
Recall Status1 |
Terminated 3 on July 25, 2018 |
Recall Number | Z-0509-2018 |
Recall Event ID |
79009 |
510(K)Number | K160126 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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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). |
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 |
Recalling Firm/ Manufacturer |
Brainlab AG Olof-Palme-Strasse 9 Munich Germany
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For Additional Information Contact | Michael Flynn 978-615-5025 |
Manufacturer Reason for Recall | Risk of unintended motion while the AIRO system is in transport mode. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JAK
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