| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00910-1 |
| Product Name/Description |
DigitalDiagnost - EasyUpgrade DR (Diagnostic digital x-ray system)
system code 712086
ARTG Number: 117662 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.
The misinterpretation of the mirror icon to be a patient right side indication could potentially lead to a misdiagnosis. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Clinical staff should follow the Instructions for Use and use lead letters to indicate body orientation of the patient or equivalent electronic markers to provide Left/Right indicators, during all x-ray image acquisitions. Philips is advising users that a software and hardware upgrade will be performed to replace the mirror icon. Philips will also provide updated Instructions for Use for the work spot and the system. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |