| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00400-1 |
| Product Name/Description |
Manual Collimator Exchange system in use with an ADAC VERTEX Plus, CARDIO, SOLUS or VERTEX V60 imaging system
(Nuclear Medicine Gamma Camera Systems)
ARTG number: 117642 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Philips Healthcare received a report that during a manual collimator exchange procedure, when the operator was attempting to slide the collimator cassette from the Collimator Storage Cabinet onto the Collimator Exchange Carriage, the cassette did not align with the carriage top guide rollers and mechanical lock. The collimator and collimator cassette fell off the carriage resulting in the operator receiving a minor injury. This could result in serious injury to a person if it comes in direct contact with the operator. Automatic Collimator Exchange system is not affected. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare is instructing their customer not to proceed with collimator exchange procedure, if a misalignment on the top and/or bottom of the guide rail between the cabinet and carriage can be visually detected Philips Healthcare service technician will fix the issue prior to the continued use of the system.
UPDATE: Philips is advising their customer that they must ensure collimator alignment is inspected via regularly scheduled Preventive Maintenance at 3 month intervals. An updated procedure for inspecting collimator alignment has been provided. This action has been closed-out on 10/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |