Z-0884-2013Class II

Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082

Name: Z-0884-2013 Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082
Creator: Philips Healthcare Inc.
Published: 2012-10-25
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-10-25 / Terminated / root cause: software

FDA source

Philips Healthcare Inc. began a recall of Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system on 2012-10-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0884-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-25
Posted: 2013-02-26
Terminated: 2014-03-31
Recalling firm: Philips North America LLC
Product: Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: Philips Medical Systems issued on October 25, 2012 an Urgent Field Safety Notice for the Digital Diagnost System informing consignees of the software upgrade. The UFSN described the problem, the hazard involved, the action to be taken by the consumer/user and the action planned by Philips. For questions contact your local Philips representative: Technical Support Line 1-800-722-9377.
Quantity in commerce: 551
Distribution: Worldwide Distribution - USA Nationwide and the Foreign countries of: Austria, Canada, Belgium, China,Denmark, France, germany, Italy, Netherlands,New Zealand, Norway, Philippines, Portugual, SOuth Korea, Spain, Switzerland, Thailand, and UK.
Product codes and lots: Systems with Eleva SW version 2.1.3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0884-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0884-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-26

Product code MQB

K982795Class IIPhilips Bucky VisionPhilips Medical Systems, Inc. / cleared 1998-11-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)