| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01033-1 |
| Product Name/Description |
MINC+ Benchtop Incubator
Reference Part Number: K-MINC-2000
Lot Number: AM109637, AM109638
ARTG 361951
(William A Cook Australia Pty Ltd - Assisted reproduction heater/incubator) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
William A. Cook Australia has identified that the MINC+ device is susceptible to losing temperature control if electrostatic discharge (static electricity) is applied to the lid of the device.
Update 19/1/2024: During further testing on the MINC+ device, it was also identified that the MINC+ is susceptible to losing temperature control when exposed to high levels of radiofrequency emissions in the range of 710-930MHz. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers may continue to use the device, however if it produces audible and visual alerts to indicate an error with temperature, the customer should
1. Immediately move any dishes to another incubator.
2. If no other incubators are available, the device can be reset to normal operation by switching off mains power to the device for ten seconds then turning the power back on.
The risk of applying electrostatic discharge to the device can be reduced by:
• Limiting physical contact with the stainless-steel magnet plate on top of the device
• Touching an earthed component such as the incubator’s braided gas hose prior to operating the device.
An authorised service agent will contact customers to arrange the updated software/firmware
Update 19.1.24: The updated software/firmware will be available from 15 April 2024.
The risk of interference from radiofrequency emitting devices can be reduced by
• Ensuring no mobile phones or wireless IT platforms are used near the MINC+ device |
| Contact Information |
1800 777 222 - William Cook Australia Customer Relations |