Date Initiated by Firm | April 01, 2011 |
Date Posted | March 27, 2012 |
Recall Status1 |
Terminated 3 on August 23, 2016 |
Recall Number | Z-1178-2012 |
Recall Event ID |
61311 |
Product Classification |
System, x-ray, stationary - Product Code KPR
|
Product | Philips Healthcare EasyDiagnost Eleva DRF 4.0
Stationary X-Ray System with DRF as an option for digital radiography. |
Code Information |
706037 |
Recalling Firm/ Manufacturer |
Philips Healthcare Inc. 3000 Minuteman Road Andover MA 01810
|
For Additional Information Contact | 978-687-1501 |
Manufacturer 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 Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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