Mobius Airo Mobile Intraoperative CT System Recalled for Data Transfer Errors
Mobius Imaging is recalling 21 Airo Mobile Intraoperative CT systems because a software error may cause incorrect or missing navigation data to transfer to the Brainlab Curve system.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a software error could lead to incorrect navigation data during surgery, representing a risk of harm where specific injury reports are not detailed in the source text.
Plain-English summary
Mobius Imaging, LLC is recalling 21 Airo Mobile Intraoperative CT I Airo systems, Model MobiCT-32. The recall affects 15 of these devices that are impacted by a specific software patch (v. 1.1.1+). The devices are distributed in the United States and internationally to Germany, the Netherlands, Belgium, Switzerland, Saudi Arabia, and Egypt.
The recall is due to a risk that an error may occur during the transfer of image and navigation data to the Brainlab Curve Image Guided Surgery Navigation System after a CT scan. This error may result in either no navigation data or incorrect navigation data being transferred to the Curve system.
Healthcare facilities and users should contact Mobius Imaging for further instructions regarding the affected serial numbers listed in the official recall notice.
The recalled product
- Product
- Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
- Manufacturer
- Mobius Imaging, LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial #s: 2251 (#1)*
- 2324 (#2)
- 2328(#3)
- 2344 (#4)
- 2346 (#5)
- AIRO-0106
- AIRO-0107*
- AIRO-0108
- AIRO-0110
- AIRO-0111
- AIRO-0112
- AIRO-0113
- AIRO-0114
- AIRO-0115
- AIRO-0116
- AIRO-0117
- AIRO-0118
- AIRO-0119
- AIRO-0120
- AIRO-0122
Distribution
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