| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00787-3 |
| Product Name/Description |
Essenta DR Compact (General purpose X-ray system)
System Number: 9890-010-88201
ARTG Number: 117662 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
Three issues requiring correction have been identified by the manufacturer:
1. During reliability tests on the steel rope, one of the springs broke and the safety catch did not hold. The safety catch mechanism does not activate due to the counteracting force of the remaining spring. As a consequence the U-arm moves down uncontrolled. The manufacturer has identified that this can occur in the field earliest after 2.5 years of operation. These 2.5 years are calculated for a worst case usage of the system.
2. During installation all 3 screws for one SIB chain wheel were found loose. If
all 3 screws of one of these wheels loosen completely, the detector carriage
and/or the tube carriage can move down uncontrolled until stopped by the
corresponding end stop.
3. During in-house testing it was detected that the life time of the wire rope is
significantly lower than the specified 10 years. The replacement of the wire
rope every 3 years is required. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is urging customers to contact them if they have any concerns and is replacing the vertical carriage, wire rope, SID chain wheels and Instructions for Use. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |