Z-1464-2012

Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option

Name: Z-1464-2012 Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option
Creator: Philips Healthcare Inc.
Published: 2012-04-03
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-04-03 / Terminated / root cause: labeling and UDI

FDA source

Philips Healthcare Inc. began a recall of Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option Intended use: Stationary radiographic system, Radiographic system, digital on 2012-04-03. The reason FDA records is "Potential misdiagnosis due to improperly automatically stitched images, improper image ruler handling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1464-2012
Status: Terminated
Initiated: 2012-04-03
Posted: 2012-04-26
Terminated: 2014-03-13
Recalling firm: Philips North America LLC
Product: Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option Intended use: Stationary radiographic system, Radiographic system, digital
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: Potential misdiagnosis due to improperly automatically stitched images, improper image ruler handling.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: The firm, Philips Healthcare Imaging, issued an "URGENT-FIELD SAFETY NOTICE" dated March 30, 2012 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to follow the instructions carefully and to not use the Philips Image Ruler for measurements. The firm plans to supply an Addendum to the Instructions For Use and a Philips Service Engineer will contact the customer as soon as the Field Action Kit is ready to be implemented. If you need any further information or support concerning this issue, please contact your local Philips representative or call 1-866-767-2822.
Quantity in commerce: 606 units
Distribution: Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech. Rep, Denmark, Finland, France, Germany, Guadeloupe, India, Indonesia, Iran, Iraq, Italy, Japan, Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Salkowski, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Ver.Arab.Emir.
Product codes and lots: Model #s 712020, 712022, 712082 All systems with Eleva software version 2.x and stitching option.

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)