—#107785

Product

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

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: 706037

Why it was recalled

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Worldwide Distribution - Including USA.

Timeline

Recall initiated: 2011-04-01
Posted by FDA: 2012-03-27
Terminated: 2016-08-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107785. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.