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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 Systemsee related information
Date Initiated by FirmDecember 07, 2022
Date PostedJanuary 17, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0957-2023
Recall Event ID 91258
510(K)NumberK180393 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductMobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
Code Information UDI-DI: 00869346000200 ALL Serial numbers
Recalling Firm/
Manufacturer		 Mobius Imaging, LLC
2 Shaker Rd Ste F100
Shirley MA 01464-2535
For Additional Information ContactStryker Technical Support
978-386-9619
Manufacturer Reason
for Recall		Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The firm will increase visibility of instructions for users to consider when transporting the unit in reverse by providing labels to be affixed onto the AIRO.
FDA Determined
Cause 2		Use error
ActionOn December 7, 2022, the firm notified customers via Urgent Medical Device Correction letters. Customers were informed that the firm would add additional warning labels to the Airo to increase visibility of instructions for users to consider when transporting an Airo TruCT unit in reverse. A service representative will contact your facility once labels are available (anticipated February 2023) to schedule a time to affix the labeling to your Airo TruCT unit. In the interim, please ensure all Airo TruCT users and other relevant personnel in your facilities are informed of this issue. If the devices have been distributed to other organizations, inform Stryker so that they may inform personnel at the new locations appropriately. If you have any questions or concerns regarding this notification, please contact shirleytechnicalsupport@stryker.com or call Stryker Technical Support at 978 386 9619.
Quantity in Commerce303
DistributionWorldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Chinese Taipei, Denmark, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Korea, Republic of Kuwait, Lithuania, Malaysia, Mexico, Morocco, Nepal, Netherlands, Norway, Pakistan, Poland, Russian Federation, Saudi Arabia, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom, Viet Nam.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAK
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