| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01094-1 |
| Product Name/Description |
Essenta DR Compact (Digital diagnostic X-Ray system)
ARTG Number: 117662 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
1. The weight of the U-arm on the Essenta DR Compacta is counterbalanced by two parallel suspension springs in the column. When a single spring breaks, there is a risk that the safety catch mechanism may not activate due to the counteracting force of the remaining spring. As a result, the U-arm moves down uncontrollably. This was observed during reliability tests on the steel rope within the vertical carriage where one of the springs broke and the safety catch did not hold. In a Post Market Risk Assessment it was detected, the item can occur in the field by 2.5 years of operation. These 2.5 years are calculated for a worst case usage of the system.
2. During in house testing it was detected that the lifetime of the wire rope for the vertical movement is significantly lower than 10 years specified in the Instructions for Use. If the rope breaks, the safety catch will hold the U-arm under all circumstances. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare is replacing the vertical carriage, wire rope and Instructions for Use (IFU). |
| Contact Information |
1800 251 400 - Philips Customer Care |