| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00922-1 |
| Product Name/Description |
ProBP 2400 Digital Blood Pressure Device
Serial Number ranges:
(21)07150001 – (21)07150620
(21)12150001 – (21)12150500
Please note: (21) is NOT part of the Serial Number. It is the Global Unique Device Identification (GUDI) Application Identifier that precedes the Serial Number on any GUDI compliant label.
ARTG Number: 232592 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
Welch Allyn has been made aware of a product quality issue which could potentially affect the ProBP 2400 Digital Blood Pressure devices manufactured by Microlife and distributed by Welch Allyn. As a result of a defective electrical component in the battery charging circuit, when the ProBP 2400 is connected to the external power supply/battery charger, a potential over-voltage battery charging condition may occur. This potential defect resides with the device, not the battery.
The over-voltage condition can result in high NiMH battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic (ABS) battery door and other adjacent plastic and foam device components.
This issue may lead to patient and/or caregiver burns as result of skin contact with melted plastic and/or delays in treatment. |
| Recall Action |
Recall |
| Recall Action Instructions |
The affected devices within the Serial Numbers specified in the customer letter are being recalled and will be replaced with new devices at no cost to affected customers.
This action has been closed out on 17/10/2018 |
| Contact Information |
02 9638 3000 - Welch Allyn Technical Support |