Philips Electronics North America Corporation recalls ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526…

Recall date

July 17, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0348-2018

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

1067 US customers 163 Canada, 917 International

Why it was recalled

Issue with ECG out cables. When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable or ECG out cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs): " On the HeartStart MRx and HeartStart XL, EFT noise may be misinterpreted as an R-wave. " On the HeartStart XL+, EFT noise can disable ECG monitoring and potentially interrupt demand mode pacing*. *Note: It is contrary to the XL+ Instructions for Use to perform demand mode pacing while using the ECG out cable or obtaining the ECG signal from a bedside monitor. The XL+ Instructions for Use includes the following warning: When pacing in Demand Mode, the ECG cable from the patient must be directly connected to the HeartStart XL+. If the user follows this warning, this problem cannot occur on the XL+.

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

What was recalled

ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2014