MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Summary
The FDA issued a Class II for MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography by Mobius Imaging, LLC. Reason: Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with.
Details
Source
Device Recall
External ID
Z-0344-2023
Action Date
2022-12-07
Status
Terminated
Category
device
Product Description
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Lot/Code Info: UDI-DI 00869346000200 Serial Numbers AIRO-0124, AIRO-0145, AIRO-0288
Quantity Affected: 3
Reason for Recall
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.
Distribution
Domestic distribution to consignees in Colorado, Tennessee, and Utah.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-18
Company
Shirley, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Mobius Imaging, LLC has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mobius Imaging, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mobius Imaging, LLC have FDA actions?
Mobius Imaging, LLC has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0344-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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