Z-0223-2024Class II

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

Name: Z-0223-2024 Mobilett Mira wireless (VA20) mobile x-ray system(s)
Creator: Siemens Medical Solutions USA, Inc
Published: 2023-10-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2023-10-05 / Open, Classified / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Mobilett Mira wireless (VA20) mobile x-ray system(s) on 2023-10-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0223-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-05
Posted: 2023-11-14
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Mobilett Mira wireless (VA20) mobile x-ray system(s)
Product code: IZL System, X-Ray, Mobile
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 4 distributed in U.S.
Distribution: US Nationwide - Worldwide
Product codes and lots: Model Number 10273100 / UDI 04056869009117 Serial 1511 2168 2525 2633

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0223-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0223-2024	Class II	Ongoing	FDA Mandated	2023-11-22	2023-11-14

Product code IZL

K111912Class IIMobilett MiraSiemens Medical Solutions USA, Inc. / cleared 2011-09-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)