The Recall Desk
HighFDA (Devices)·Z-0344-2023·Announced 2022-12-07

Mobile CT Scanner Battery Fire Risk in Units With Bypassed Monitoring

Mobius Imaging is recalling MobiCT-32 AIRO Mobile CT Scanner units due to a reported battery fire in devices where battery monitoring systems were bypassed. The affected units' batteries must be replaced.

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: FDA Class II device with a reported battery fire incident where a monitoring system was bypassed. While battery fires pose a risk of serious harm, no hospitalizations or injuries are reported in the source text, qualifying this as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Mobius Imaging is recalling the MobiCT-32 AIRO Mobile CT Scanner (software version 2.1.1). Three units with serial numbers AIRO-0124, AIRO-0145, and AIRO-0288 are affected. These units were distributed to consignees in Colorado, Tennessee, and Utah.

A battery fire was reported in one of these units that had previously been charged with its battery monitoring system bypassed. Units with bypassed battery monitoring systems are subject to this fire hazard. The affected units require immediate battery replacement.

Customers with affected units should contact Mobius Imaging for battery replacement instructions.

The recalled product

Product
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Manufacturer
Mobius Imaging, LLC
Category
Medical Device — Diagnostic Imaging / CT Scanner
Hazard
  • battery-fire

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 (3)

  • UDI-DI 00869346000200 Serial Numbers AIRO-0124
  • AIRO-0145
  • AIRO-0288

Distribution

Distribution scope not specified by the agency.

Related recalls

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