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[Recalled] Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system — When the operator for a wall stand view selects an "image rotation" d

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

ProductPhilips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system
Brand / manufacturerPhilips Healthcare Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0884-2013
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date25 October 2012

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.

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 Philips Healthcare 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.

Shop Recalled Philips DigitalDiagnost Ray
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