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Open, Classified

Mobilett Mira wireless (VA20) mobile x-ray system(s)

FDA Recall Z-0223-2024 · Posted 2023-11-14

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusOpen, Classified
Product CodeIZL
Date Initiated2023-10-05
Product Quantity4 distributed in U.S.

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.

Firm Action

Customer 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide - Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111912MOBILETT MIRASiemens Medical Solutions USA, Inc. · 2011-09-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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