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

FDA device recall Z-1178-2012 · posted 2012-03-27 · Terminated

Recall details

Recalling firm

Philips Healthcare Inc.

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.

Action taken

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.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

KPR

Quantity affected

96

Distribution

Worldwide Distribution - Including USA.

Date initiated

2011-04-01

Date posted

2012-03-27

Date terminated

2016-08-23

Location

Andover, MA