RecallRadar

FDA Device recall Z-0900-2013

Philips Digital Diagnost Stationary radiographic system

On 2013-03-13 the FDA classified a Class II recall of Philips Digital Diagnost Stationary radiographic system by Philips Healthcare, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0900-2013
ClassificationClass II
Statusterminated
Initiated2012-10-30
Published2013-03-13
Last updated2026-09-13 11:53 UTC
CompanyPhilips Healthcare
DistributionUS

Product

Philips Digital Diagnost Stationary radiographic system

Reason

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.

Identifiers

code_infoAll Digital Diagnost systems with Eleva software version 3.0.x

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0900-2013%22

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