Reported Aug 26, 2026 · Ongoing · Updated Sep 16, 2026
Cardiac Workstation 5000. Product Number: 860439.
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- Cardiac Workstation 5000
- Product Number860439
- Lot codes and dates
- Product Number860439
- UDI(01)00884838094826
- Serial Numbers
166 of 166 codes
US42510185US42510184US52510209US52510200US52510226US52510228US62510247US62510250US62510256US72510286US82510299US82510307US82510300US82510313US82510318US82510314US82510335US82510336US82510341US82510325US92510351US92510353US92510354US92510361US92510362US92510370USN2510413USN2510414USN2510434USN2510435USN2510437USD2510506USD2510519US12610582USD2510513US12610598US22610609US22610683US22610691US22610689US32610737US32610744US32610759US32610766US32610749US32610739US32610751USD2510516USD2510510USD2510517USD2510529USD2510509US32610752US32610753US32610879US32610880US32610901US32610914US42610946US32610915
- Amount recalled
- 796 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Device will intermittently provide inaccurate data related to native heart rate.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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