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Lower risk Medical device recall · FDA · Published March 23, 2021

Philips SureSigns VM4/VM6/VM8 Patient Monitors: Pediatric Heart Rate Inaccuracy Risk

Philips recalls certain SureSigns VM4, VM6, and VM8 patient monitors sold in China for potential pediatric heart rate inaccuracies in high-rate scenarios.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1326-2021Medical devicePhilips ›
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Contact the company

Recalling firmPhilips North America, LLC3000 Minuteman Rd · Andover, MA 01810-1032
✎ GovInfoNow plain-language explainer

Philips is recalling specific SureSigns patient monitors sold in China due to a risk of inaccurate heart rate readings in pediatric mode when the heart rate exceeds 300 bpm. This could lead to incorrect medical decisions for children. Read more at govinfonow.com/recall/62994-philips-suresigns-vm4-vm6-vm8-patient-monitors-pediatric-heart-rate.

Source Summary by GovInfoNow · govinfonow.com/recall/62994-philips-suresigns-vm4-vm6-vm8-patient-monitors-pediatric-heart-rate · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1326-2021

Cite this page

“Philips SureSigns VM4/VM6/VM8 Patient Monitors: Pediatric Heart Rate Inaccuracy Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62994-philips-suresigns-vm4-vm6-vm8-patient-monitors-pediatric-heart-rate. Based on FDA recall #Z-1326-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1326-2021%22&limit=1).

Philips North America LLC recalled Philips SureSigns VM4, VM6 and VM8 patient monitors distributed in China due to heart rate meter accuracy failures in pediatric mode, according to the FDA on March 23, 2021.

How to tell if you have it

  • Brand: Philips
  • Product names: SureSigns VM4, SureSigns VM6, SureSigns VM8
  • Model numbers: 863063, 863085, 863064, 863065, 863086, 863066, 863068, 863087, 863088
  • Other model numbers: 453564021961, 453564021971, 53564022001, 453564022041, 53564022081, 453564024371, 453564024401, 453564024421, 453564024441, 453564024461, 453564024481
  • Software version: SW A.02.63
  • Units affected: 31773
  • Distribution: China

The hazard

In pediatric mode, when the input signal rate is over 300 bpm, the indicated heart rate will be lower than this upper limit. The products fail to comply with Chinese Standard YY1079-2008 clauses 4.2.6 and 4.2.7.3.

Context

GovInfoNow's records show Philips North America LLC has 129 other recalls on record since July 12, 2017. Recent recalls include the Achieva 1.5T systems recalled on August 21, 2026, and the Spectral CT 7500 Scanner recalled on August 18, 2026. Other recent recalls of similar products include Boston Scientific LUX-Dx II Plus Model M312 (March 30, 2026), Boston Scientific LUX-DX II Arrythmia Detector Recall (March 30, 2026), and Boston Scientific CRT-P Pacemakers (March 19, 2026).

How to tell if you have this one

Check for model numbers 863063-863088 or software version SW A.02.63 on the monitor. These products were sold in China only.

  • Brand
    Philips
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Model Numbers

    Look for model numbers 863063, 863064, 863065, 863066, 863068, 863085, 863086, or software version SW A.02.63.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

1. Firm started the recall: Mar 23, 202112. FDA classified it Class II: Mar 30, 202123. Published in FDA’s Enforcement Report: Apr 7, 202134. FDA terminated the recall: Sep 28, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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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-1326-2021 (March 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1326-2021 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA