Philips North America LLC recalls Cardiac Workstation 5000. Product Number: 860439.
Reason for recall
Device will intermittently provide inaccurate data related to native heart rate.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Cardiac Workstation 5000. Product Number:860439166 affected lotsUS42510185US42510184US52510209US52510200US52510226US52510228US62510247US62510250
+158 more
US62510256US72510286US82510299US82510307US82510300US82510313US82510318US82510314US82510335US82510336US82510341US82510325US92510351US92510353US92510354US92510361US92510362US92510370USN2510413USN2510414USN2510434USN2510435USN2510437USD2510506USD2510519US12610582USD2510513US12610598US22610609US22610683US22610691US22610689US32610737US32610744US32610759US32610766US32610749US32610739US32610751USD2510516USD2510510USD2510517USD2510529USD2510509US32610752US32610753US32610879US32610880US32610901US32610914US42610946US32610915US32610941US32610932US42610943US42610942US42610959US42610958US42610955US42610974US42610967US42610956US42610993US42610960CN72410032CN92410061CNO2410064CNO2410068CNN2410075CND2410080CND2410101CND2410103CN12510116CN12510136CN22510140CN22510142CN22510146CN32510148CN32510161CN42510168CN42510181CN42510183CN52510204CN52510201CN52510217CN62510239CN62510241CN62510242CN62510253CN62510254CN62510251CN72510275CN72510282CN72510281CN72510285CN72510289CN72510288CN72510293CN72510297CN82510305CN82510310CN82510323CN82510324CN82510321CN92510343CN92510364CN92510365CN92510367CN92510374CNO2510380CNO2510392CNO2510383CNO2510386CNO2510396CNN2510412CNN2510410CNN2510427CNN2510443CNN2510444CNN2510454CNN2510485CNN2510486CND2510503CND2510502CND2510508CND2510528CND2510530CND2510566CND2510575CND2510574CN12610585CN12610590CN12610595CN12610593CN22610612CN22610681CN22610707CN22610735CN32610755CN32610760CN32610761CN32610762CN32610763CN32610765CN32610818CN32610826CN32610910CN32610913CN32610912CN32610924CN32610923CN32610929CN32610930CN32610933CN42610944CN42610951CN42610970US42610994
What the firm is doing
Philips notified consignees on about 07/01/2026 via URGENT Medical Device Correction letter. Consignees were informed that they could continue the use of the device but to refer to the information within the notification letter, disable the automatic Standby feature on the Cardiac Workstation and avoid manually putting the Cardiac Workstation in Standby mode to minimize the inaccurate heart rate value from occurring, and to pass the notice to all those who need to be aware within each organization or to any organization where affected product(s) have been potentially transferred. Additionally, consignees were requested to place the Urgent Medical Device Correction letter with the documentation of the Cardiac Workstation and associated devices in a place where it is most likely to be seen and viewed. Philips representatives will contact consignees to arrange an upgrade to the Cardiac Workstation Release 1.2.0.7.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Croatia, Czech Republic, Dominican Republic, France, Germany, Gibraltar, Hong Kong, Iceland, Ireland, Iraq, Italy, Luxembourg, Malta, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2955-2026
- FDA 510(k) clearance · K241556The device's official FDA premarket clearance record
- FDA device classification · DPSOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.2340The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Philips North America LlcSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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