Philips SureSigns VS4 Government Bundle: Pulse Rate Monitoring Issue

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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 SureSigns VS4 Government Bundle monitors because their software stops measuring pulse rates above 240 beats per minute. This could mean critical heart rate alarms aren't triggered during emergencies.

Why it’s dangerous

The monitor's software intentionally blocks pulse rates above 240 beats per minute. This prevents the device from displaying or alarming for potentially life-threatening heart rates. The hazard occurs during normal use when monitoring patients.

Who’s affected

Healthcare providers using this monitor for patient monitoring are most at risk. Patients with heart rates above 240 bpm may not receive timely warnings.

How to tell if you have this one

Check for the product number 863286 on the SureSigns VS4 Government Bundle. Serial numbers start with (01)00884838028890(21) or (01)00884838087075(21) followed by additional digits.

Brand
Philips
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Monitor Settings
Verify if the monitor displays pulse rates above 240 beats per minute. If it shows no readings, contact Philips for assistance.

✎ GovInfoNow

Questions people ask

Does this recall affect home use?

The recall is for government healthcare use only, as specified in the product description.

How can I confirm if my monitor is affected?

Check the product number 863286 and serial numbers starting with (01)00884838028890(21) or (01)00884838087075(21).

Is there a fix for this issue?

The recall record does not specify a remedy or fix.

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-1324-2019 — Philips Philips

Hello,

I own a Philips that is covered by recall Z-1324-2019 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-1324-2019 (April 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1324-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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 SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP,

Use caution until it’s fixed