| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2020-RN-00874-1 |
| Product Name/Description |
Blood Monitoring Unit BMU 40
Product Code: 701040852
Affected Serial Number Range: From 90002001 to 90002313
ARTG 158185
(Getinge Australia Pty Ltd - Analyser, blood gas, extracorporeal) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
25/09/2020 |
| Responsible Entity |
|
| Reason/Issue |
Getinge Australia is advising that the printed circuit board (PCBA Connector) of the BMU40 was designed with a short creepage distance. This PCBA Connector is positioned in the inner and backside of the metal enclosure of the BMU40.
Taking into consideration the product specifications, the mitigating design factors, as well as the factors that may contribute to product risk, the following potential health consequences (harms) could occur:
- Potential of electric shock.
- Possible absence or potential loss of patient data during device replacement.
- Procedural/use delay during device replacement.
- User inconvenience during device replacement.
Maquet/Getinge has not received any reports of serious injuries or death due to the malfunction of the PCBA Connector. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised that Getinge will be in contact to replace the PCBA Connector on the affected products, with parts available from Mid December 2020.
In the interim, customers may continue to use the BMU40 by:
- Using the equipotential bonding connector on the backside of the BMU40; and
- Not connecting external devices to the BMU40 serial ports (Com 1/Com 2) with an operational/ communication voltage outside the range of ±25Vdc.
This action has been closed out on 22/01/2024 |
| Contact Information |
1800 438 464 - Getinge Customer Service |