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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 Stryker Australia Pty Ltd
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