Type of Product |
Medical Device |
TGA Recall Reference |
RC-2016-RN-00754-1 |
Product Name/Description |
PowerPro Ambulance Cots
Catalogue Number: 6506000000
Multiple Lot Numbers
ARTG Number: 197659 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
7/06/2016 |
Responsible Entity |
|
Reason/Issue |
Stryker has become aware that the supplier has made a manufacturing transfer from their Tier Two supplier which affected the quality of the boards supplied to Stryker. As a result of workmanship issues, the boards have the potential to short circuit and overheat. There is a high probability of limited (minor, transient) harm, specifically minor respiratory irritation, not requiring medical intervention and untended lowering or cot dropping to the lowest position (no cot tip). Faulty units will not work as intended. There have been no reports of injury associated with this issue. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Stryker is advising users to inspect stock for the affected lot numbers. Any affected devices will be corrected, and can continue to be used until the correction has been completed. This action has been closed-out on 15/03/2018. |
Contact Information |
02 9467 1175 - Stryker |