Z-2495-2019Class II

Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131

Name: Z-2495-2019 Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131
Creator: Philips North America, LLC
Published: 2019-07-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2019-07-19 / Terminated / root cause: manufacturing process

FDA source

Philips North America, LLC began a recall of Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available... on 2019-07-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2495-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-19
Posted: 2019-09-09
Terminated: 2020-06-03
Recalling firm: Philips North America LLC
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
Product code: DSA Cable, Transducer And Electrode, Patient, (Including Connector)
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 280 boxes ( 5600 leadsets)
Distribution: Worldwide Distribution - US Nationwide State KY AZ CA UT OH NY SC CO FL IN TX ND KS GA Canada Germany
Product codes and lots: Lot codes: 03/18, 05/18 and 06/18

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2495-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2495-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-09

Product code DSA

K110287Class IIPhilips ECG Leadwire SetPhilips Medical Systems / cleared 2011-02-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)