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Terminated

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

FDA Recall Z-2495-2019 · Posted None

Recalling FirmPhilips North America, LLC
Recall StatusTerminated
Product CodeDSA
Date Initiated2019-07-19
Date Terminated2020-06-03
Product Quantity280 boxes ( 5600 leadsets)

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.

Firm Action

Philips sent a Customer Information letter dated July 2019 to affected customers. The letter identified the affected product, problem and actions to betaken. Customers were instructed to: 1. To identify all affected limb lead sets. 2. To fill-out, sign and send a reply form that is provided. 3. To discard affected limb lead sets following approved medical waste disposal methods per facility and/or local regulations. 4. Do not return any affected product to Philips if you need any further information or support concerning this issue, please contact your local Philips representative.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110287PHILIPS ECG LEADWIRE SETPhilips Medical Systems · 2011-02-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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