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U.S. Department of Health and Human Services

Class 2 Device Recall Mobilett Mira

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 Class 2 Device Recall Mobilett Mirasee related information
Date Initiated by FirmOctober 05, 2023
Date PostedNovember 14, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0223-2024
Recall Event ID 93304
510(K)NumberK111912 
Product Classification System, x-ray, mobile - Product Code IZL
ProductMobilett Mira wireless (VA20) mobile x-ray system(s)
Code Information Model Number 10273100 / UDI 04056869009117 Serial 1511 2168 2525 2633
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactRebecca Tudor
484-323-4198
Manufacturer Reason
for Recall		Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray is applied correctly. By means of the additional visual indicator (exposure LED light) the operator can monitor the x ray release. Also, after a successful x ray exposure, the clinical image is displayed on the monitor.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionCustomer notification by means of a Customer Safety Advisory Notice (via electronic mail or FedEx) alerting customers to the lack of acoustic signal issue and providing instructions to monitor the visual indicator (exposure LED light) to avoid additional, unnecessary x-ray dose. The CSAN also includes the plan for the affected D810 boards. The boards (containing the faulty mounting of the buzzer) will be replaced, free of charge, at the customer site with field corrective action XP042/23/P. There is no software update.
Quantity in Commerce4 distributed in U.S.
DistributionUS Nationwide - Worldwide
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 = IZL
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