| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01075-1 |
| Product Name/Description |
Getinge 46-Series Washer Disinfector with PACS 300 module
(used for the cleaning, decontamination and disinfecting (by heat) reusable surgical instruments, anaesthesia equipment, shoes and other operational utensils)
Manufactured between 2004 and 2008
ARTG Number: 125655 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
Investigations have shown that the overheating protection system of the heating element may fail to function under certain circumstances. This could result in a burn or respiratory complications as a result of inhaling smoke. THe reported overheating events have been confined to the machines. Therefore, the probability of occurrence of harm to person based on available evidence is considered remote. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Getinge is advising customers that a customer service representative will be contacting users to replace the affected overheating protective system. Given the low probability to harm, Getinge is advising that it is considered safe for a normal user who services and uses the machine as intended to continue using the machines while waiting for replacement. |
| Contact Information |
1300 155 500 - Getinge Customer Support |