Philips IntelliVue Patient Monitors: Distorted ECG ST-Segment Risk
Philips recalls IntelliVue Multi Measurement Servers with 12-lead ECG monitoring that may show distorted ST-segments, potentially affecting patient diagnosis. Affected models include M300IA/AL, M3002A, M8102A, M8105A with specific firmware and 12-lead options.
Use caution until it’s fixed
Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors
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What happened, in plain English
Philips is recalling certain IntelliVue Patient Monitors that may show distorted ST-segments on 12-lead ECG readings. This could lead to incorrect patient diagnoses if not addressed, as the monitors are used in hospitals for critical patient monitoring. Read more at govinfonow.com/recall/73123-philips-intellivue-patient-monitors-distorted-ecg-st-segment-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73123-philips-intellivue-patient-monitors-distorted-ecg-st-segment-risk · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0292-2018
Cite this page
“Philips IntelliVue Patient Monitors: Distorted ECG ST-Segment Risk.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73123-philips-intellivue-patient-monitors-distorted-ecg-st-segment-risk. Based on FDA recall #Z-0292-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0292-2018%22&limit=1).
Why it’s dangerous
The monitors may display distorted ST-segments when using 12-lead ECG monitoring, which can lead to incorrect patient diagnoses. This is a potential issue for critical patient monitoring in hospital settings where accurate readings are essential.
Who’s affected
Healthcare professionals using Philips IntelliVue Patient Monitors in hospitals for patient monitoring are most at risk. The recall affects specific models with certain firmware versions and 12-lead options.
How to tell if you have this one
Check if your monitor has model numbers M300IA/AL, M3002A, M8102A, or M8105A with ECO firmware revision E.0 1.22 and the 12-lead option C#12. The product was sold with specific catalog numbers and lots listed on the consignee list.
- Brand
Philips- Category
Medical device
What to do — step by step
Check Monitor Model
Identify your monitor's model number to see if it matches M300IA/AL, M3002A, M8102A, or M8105A with the specified firmware and 12-lead option.
Contact Philips Support
Reach out to Philips for guidance on whether your monitor is affected and what steps to take next.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution and US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 4 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-0292-2018 (August 23, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0292-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 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.