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[Recalled] Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system — During regular product monitoring, firm became aware of a potential issue with… | FDA 2012-04-30

recall fda device united-states

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

ProductSiemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system
Brand / manufacturerSiemens Medical Solutions USA, Inc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2367-2012
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date30 April 2012
EAN / barcode10273100

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira system, (serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054. During normal clinical operation the center screw on the driving wheel may become loose resulting in system immobilization. There is no risk of the system tipping over or collapsing on the floor, however the system may tilt t

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Siemens Medical Solutions USA, Inc

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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