Medical device recalls Moderate risk

Welch Allyn Inc recalls Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch…

Recall date
February 27, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1777-2017
FDA classification
Class II
Brand / firm
Welch Allyn Inc
Sold / distributed
Worldwide Distribution - USA (nationwide) Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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