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[Recalled] Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices. — Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System bec

recall fda device united-states

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductShimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.
Brand / manufacturerShimadzu Medical Systems
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1569-2014
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date03 April 2014

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.

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 Shimadzu Medical Systems

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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