Z-1777-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2017
- Initiation Date
- February 27, 2017
- Termination Date
- June 14, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 981 units
Product Description
Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei, 11492, Taiwan, R.O.C. --- Microlife AG Espenstrasse 139 9443 Widnau, Switzerland
Reason for Recall
A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 may potentially cause an over-voltage battery charging condition when the device is connected to the external power supply/battery charger. 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 battery door and other adjacent plastic and foam device components.
Distribution Pattern
Worldwide Distribution - USA (nationwide) Distribution
Code Information
Lot Number 0715: Serial Number range (21)07150001 - (21)07150620; Lot Number 1215: Serial Number range (21)12150001 - (21)12150500; --- 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.