Z-1283-2012

Philips Easy Diagnost Eleva DRF, Software release 4.0 Fluoroscopic image-intensified Stationary X-Ray System

Name: Z-1283-2012 Philips Easy Diagnost Eleva DRF, Software release 4.0 Fluoroscopic image-intensified Stationary X-Ray System
Creator: Philips Medical Systems Gmbh, DMC
Published: 2012-03-09
License: https://open.fda.gov/license/

Philips Medical Systems DMC GmbH / initiated 2012-03-09 / Terminated / root cause: software

FDA source

Philips Medical Systems Gmbh, DMC began a recall of Philips Easy Diagnost Eleva DRF, Software release 4.0 Fluoroscopic image-intensified Stationary X-Ray System on 2012-03-09. The reason FDA records is "Underexposed image due to lag in switching between auxiliaries". 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-1283-2012
Status: Terminated
Initiated: 2012-03-09
Posted: 2012-03-23
Terminated: 2013-05-23
Recalling firm: Philips Medical Systems DMC GmbH
Product: Philips Easy Diagnost Eleva DRF, Software release 4.0 Fluoroscopic image-intensified Stationary X-Ray System.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Underexposed image due to lag in switching between auxiliaries
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated February 27, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The firm provided a work around for customers to use until a software update can be installed. Customers should contact their local Philips representative for questions regarding this notice.
Quantity in commerce: 88 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Australia, Germany, Indonesia, Malaysia, Saudi-Arabia, Singapore, and Thailand.
Product codes and lots: Software release 4.0

Product code JAA

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)