# FDA recall Z-2495-2019

> **Philips North  America, LLC** · Class II · device recall initiated 2019-07-19.

## Product

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

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

## Key facts

- **Recall number:** Z-2495-2019
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-19
- **Report date:** 2019-09-18
- **Termination date:** 2020-06-03

- **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-2495-2019

## Citation

> AI Analytics. FDA recall Z-2495-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-2495-2019. Source: US FDA. Licensed CC0.

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