Home / Recalls / Philips North America, LLC / Z-2495-2019

Z-2495-2019 Class II Terminated

Recalled by Philips North America, LLC — Andover, MA

Recall Details

Product Type
Devices
Report Date
September 18, 2019
Initiation Date
July 19, 2019
Termination Date
June 3, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
280 boxes ( 5600 leadsets)

Product Description

Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration

Reason for Recall

The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. which may prevent or impede the performance of I 2-Lead ECG measurements.

Distribution Pattern

Worldwide Distribution - US Nationwide State KY AZ CA UT OH NY SC CO FL IN TX ND KS GA Canada Germany

Code Information

Lot codes: 03/18, 05/18 and 06/18

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