Philips Healthcare EasyDiagnost Eleva DRF 4.0 Stationary X-Ray System with DRF as an option for digital radiography.
This recall has been terminated (originally issued March 27, 2012).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- April 1, 2011
- Posted
- March 27, 2012
- Terminated
- August 23, 2016
- Recall Number
- Z-1178-2012
- Quantity
- 96
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution - Including USA.
Lot / Code Info
706037
Root Cause
Radiation Control for Health and Safety Act
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.