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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83560

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 19, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips North America, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2495-2019
Recall number
Z-2495-2019
Initiated
July 19, 2019
Classification
Class II
Status
Terminated
Quantity
280 boxes ( 5600 leadsets)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot codes: 03/18, 05/18 and 06/18

Distribution pattern

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