Z-1178-2012

Philips Healthcare EasyDiagnost Eleva DRF 4.0 Stationary X-Ray System with DRF as an option for digital...

Name: Z-1178-2012 Philips Healthcare EasyDiagnost Eleva DRF 4.0 Stationary X-Ray System with DRF as an option for digital...
Creator: Philips Healthcare Inc.
Published: 2011-04-01
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-04-01 / Terminated

FDA source

Philips Healthcare Inc. began a recall of Philips Healthcare EasyDiagnost Eleva DRF 4.0 Stationary X-Ray System with DRF as an option for digital radiography on 2011-04-01. The reason FDA records is "It was discovered in some instances the detector did not reset as quickly as the user prompted a change form one image receptor (auxiliary) to the next, and then back again". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1178-2012
Status: Terminated
Initiated: 2011-04-01
Posted: 2012-03-27
Terminated: 2016-08-23
Recalling firm: Philips North America LLC
Product: Philips Healthcare EasyDiagnost Eleva DRF 4.0 Stationary X-Ray System with DRF as an option for digital radiography.
Product code: KPR System, X-Ray, Stationary
Reason for recall: It was discovered in some instances the detector did not reset as quickly as the user prompted a change form one image receptor (auxiliary) to the next, and then back again.
FDA root cause: Radiation Control for Health and Safety Act
Action: An Important Electronic Product Radiation Warning letter, dated February 28, 2012, was sent to customers. The letter identified the affected product, a description of the issue, the hazard involved, along with the actions to be taken and planned. Customers were to use one of the three work-a-rounds provided. The issue will be corrected with Field Change Order 70600064, which consists of a Software Update 4.0.2SP Service Pack installed on the system. If further information or support is needed, customers can contact Dominic Siewko at 978-659-7936.
Quantity in commerce: 96
Distribution: Worldwide Distribution - Including USA.
Product codes and lots: 706037

Product code KPR

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)