| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00143-1 |
| Product Name/Description |
Carestation 620 A1, 650 A1, and 650c A1 Anaesthesia devices and service kits
Serial Numbers:
Carestation 620 A1 (GTIN: 00840682103985): SM615020004WA to SM616010008WA
Carestation 650 A1 (GTIN: 00840682103947): SM715020005WA to SM716010008WA
Carestation 650c A1 (GTIN: 00840682103954): SM815020001WA to SM815500001WA
Service kits affected
2071003-001-S , BTV SWITCH ASSEMBLY
2081000-001-S , ASSY BOTTOM BC
2082466-001-S, ASSY BOTTOM BC AUS FEMALE 22
ARTG Number: 93955 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue with the BTV switch of certain Carestation 600 Series Anaesthesia systems.
The BTV switch could become difficult to move between mechanical ventilation and manual bag modes or remain in a position where it is not possible to ventilate the patient using the anaesthesia system. This issue could result in loss of patient ventilation potentially resulting in hypoxia.
There have been no customer complaints or injuries reported as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising users that the systems can continued to be used. However users should ensure back up ventilation, independent of the anaesthesia machine is available. GE is advising users all affected devices will be corrected. |
| Contact Information |
1800 659 465 - GE National Call Centre |