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U.S. Department of Health and Human Services

Class 2 Device Recall AIRO Mobile CT System

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  Class 2 Device Recall AIRO Mobile CT System see related information
Date Initiated by Firm November 18, 2022
Date Posted December 06, 2022
Recall Status1 Open3, Classified
Recall Number Z-0344-2023
Recall Event ID 91178
510(K)Number K180393  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Code Information UDI-DI 00869346000200 Serial Numbers AIRO-0124, AIRO-0145, AIRO-0288
Recalling Firm/
Mobius Imaging, LLC
2 Shaker Rd Ste F100
Shirley MA 01464-2535
For Additional Information Contact Stryker Technical Support
Manufacturer 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.
FDA Determined
Cause 2
Action On November 18, 2022, the firm notified affected customers via Urgent Medical Device Correction letters. Customers were informed that a service representative will contact their facility to schedule a time to replace the batteries in the affected devices. The customer does not need to take additional action while waiting for the battery preplacement. If you have any questions or concerns regarding this update, please contact shirleytechnicalsupport@stryker.com or call Stryker Technical Support at 978 386 9619.
Quantity in Commerce 3
Distribution Domestic distribution to consignees in Colorado, Tennessee, and Utah.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = Mobius Imaging, LLC