# FDA recall Z-0348-2018

> **Philips Electronics North  America Corporation** · Class II · device recall initiated 2017-07-17.

## Product

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

## Reason for recall

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+.

## Distribution

1067 US customers  163 Canada, 917 International

## Key facts

- **Recall number:** Z-0348-2018
- **Recalling firm:** Philips Electronics North  America Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-17
- **Report date:** 2018-01-24
- **Termination date:** 2018-07-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0348-2018

## Citation

> AI Analytics. FDA recall Z-0348-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0348-2018. Source: US FDA. Licensed CC0.

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