Type of Product |
Medical Device |
TGA Recall Reference |
RC-2015-RN-00967-1 |
Product Name/Description |
Prism Medical P300 and C300 Lifts
Lifter P300 Models: 303050; 303051 Serial: P303470 – 479, P304158/164/171/172, P304536 – 539, P304866/867, P305116/118, P305125 – 127, P305130/134/135
Lifter C300 Models: 330050; 330053 Serial: C303221/224/225, CQ303107 – 116
Lifts manufactured prior to 8 June 2015
ARTG Number: 169639 |
Recall Action Level |
Consumer |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
30/09/2015 |
Responsible Entity |
|
Reason/Issue |
Prism has been made aware of 17 incidents involving 300 series lifts in which the drive gear shaft has broken, eliminating the lifts ability to raise or lower a patient. Of these 17 incidents we have discovered 3 in which the free fall protection system did not engage properly. If both of these incidents occur at the same time there is a risk for the person being supported by the lift to drop unexpectedly. The patients involved in the 3 incidents were not seriously injured and did not require medical attention. |
Recall Action |
Recall |
Recall Action Instructions |
Rehab Assist will replacing the affected units with a new unit. For further information please see https://www.tga.gov.au/alert/prism-medical-p300-and-c300-ceiling-hoist. This action has been closed-out on 18/08/2016. |
Contact Information |
03 9729 7978 - Rehab Assist |