FDAClass IIDecember 7, 2022

MobiCT-32 AIRO Mobile CT Scanner recall

MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1

Why was MobiCT-32 AIRO Mobile CT Scanner recalled?

Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems were bypassed to charge the batteries; the batteries in these units require replacing.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Recalling firm
Mobius Imaging, LLC
Quantity
3
Distribution
Domestic distribution to consignees in Colorado, Tennessee, and Utah.
Recall date
December 7, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
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