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Recall Observatory FDA recall evidence

Device product

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

Z-1777-2017

February 27, 2017

Class II

Product summary

Firm
Welch Allyn Inc
Event
Event 76552
Status
Terminated
Classification
Class II
Quantity
981 units
Official record key
device-enforcement:Z-1777-2017

Official wording

Reason: 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.

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.

Distribution pattern: Worldwide Distribution - USA (nationwide) Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.