Philips 5-Lead ECG Leads Recall: May Impede ECG Measurements

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Contact the company & request your remedy

Recalling firmPhilips North America, LLC3000 Minuteman Rd · Andover, MA 01810-1032

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Philips is recalling bedside ECG lead sets that might not work properly due to connector thickness. This could lead to inaccurate heart monitoring readings during medical use.

Why it’s dangerous

The connector thickness on affected leads might be too large, causing the ECG machine to give incorrect heart rate readings. This could lead to improper medical decisions if the leads are used for bedside monitoring.

Who’s affected

Healthcare workers using Philips bedside ECG leads with model #989803173131 from production lots 03/18, 05/18, and 06/18 are most at risk. Patients receiving monitoring with these leads could experience inaccurate heart readings.

How to tell if you have this one

Check for model number 989803173131 on the lead set. Affected units were produced in lots 03/18, 05/18, and 06/18.

Brand
Philips
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Number
Look for model number 989803173131 on the lead set.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The connector thickness on affected leads may be greater than specified, which could prevent accurate ECG measurements.

What should I do if I have these leads?

The recall record does not specify a remedy, so check with Philips for guidance.

Which lots are affected?

Lots 03/18, 05/18, and 06/18.

Take action

Contact Philips

We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2495-2019 — Philips Philips

Hello,

I own a Philips that is covered by recall Z-2495-2019 from Philips.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2495-2019 (July 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2495-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Philips North America, LLC recalls Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead

Lower-risk recall