Reported Feb 14, 2018 · Terminated

AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed…

Brainlab AG

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Brainlab AG · Olof-Palme-Strasse 9 · Munich, N/A · N/A

Is this the product you have?

  • AIRO Mobile CT System
  • Model NumberMobiCT-32
  • Product UsageThe 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)
Lot codes and dates
  • All units released since April 2014
  • Serial numbers

    102 of 102 codes

    • 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
Amount recalled
102

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 25, 2018 · Data as of Sep 19, 6:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.