| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00587-1 |
| Product Name/Description |
Miele washer-disinfectors when connected to an in-house network
Model Numbers: PG 8527, PG 8528, PG 8535 and PG 8536
ARTG Number: 280003 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
Miele have identified an IT security vulnerability affecting specific models of Miele washer-disinfectors. These washer-disinfectors feature a network interface for connection to an in-house network for cycle documentation purposes. In the event of an attack on the in-house network of a hospital, a laboratory or a surgery, there is a risk that data from Miele washer-disinfectors can be read out and/or replaced. This data is for the most part binary code. To date, there has been no evidence indicating that such an incident has ever occurred. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Miele recommends users implement the following:
1. Ensure that all relevant staff members using the machine are informed of this product correction;
2. Do not enable access to the machine via the Internet. If the machine is accessible via the Internet, deactivate any Internet connections immediately;
3. Only operate these machines in a separate section of the network (physically separated or protected by access authorisation systems by configuring routers/firewalls). In this network, only operate the systems required for the documentation of reprocessing results (e.g. PC and printer);and
4. Access to any affected machine and access-authorised systems should be limited exclusively to persons requiring access.
4.1 Access-authorised systems should be protected using strong passwords.
4.2 Alter existing passwords on machines (cf. programming manual).
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
07 3632 2453 - Miele Australia |