Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2495-2019 — 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

U.S. FDA — Device Enforcement · United States · 2019-07-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2495-2019
Date of alert
2019-07-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
989803173131
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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