Z-0767-2013Class II

Phillips Easy Diagnost Eleva DRF. Model Number: 706034

Name: Z-0767-2013 Phillips Easy Diagnost Eleva DRF. Model Number: 706034
Creator: Philips Healthcare Inc.
Published: 2013-01-16
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-01-16 / Terminated / root cause: software

FDA source

Philips Healthcare Inc. began a recall of Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications on 2013-01-16. FDA classified it as Class II and gives the reason as "The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system". 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-0767-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-16
Posted: 2013-02-01
Terminated: 2017-01-23
Recalling firm: Philips North America LLC
Product: Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
Product code: KPR System, X-Ray, Stationary
Reason for recall: The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Phillips issued an Urgent Field Safety Notice to all customers on January 14, 2013, to notify users that the Phillips EasyDiagnost Eleva systems, release 3.0 has a mirror icon that could be misinterpereted and could potentially lead to misdiagnosis. Philips will upgrade the system to version 3.1 which involves software and hardware upgrades of the system. This software provides a replacement icon that reduces the risk of the potential misinterpretation of the original mirror icon. Additionally, Philips will provide updated Instructions for Use (IFU) for the Eleva workspot and the EasyDiagnost 3.1 system and an addendum to the EasyDiagnost system IFU. Users will be contacted by Phillips to schedule the installation. For questions contact your local Philips representative: 1-800-722-9377.
Quantity in commerce: 14 units
Distribution: US Nationwide Distribution including the states of FL, CA, WA, AZ, NC, KY, DE, AZ and MO.
Product codes and lots: Serial Numbers 362600, 362601, 364209, 364210, 375245, 375850, 376439, 384396, 387492, 398185, 399440, 399621, 399623, 402409

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0767-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0767-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-01

Product code KPR

K031535Class IIPhilips Easydiagnost ElevaPhilips Medical Systems North America Co. / cleared 2003-06-17

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)