Z-2955-2026Class II

Cardiac Workstation 5000. Product Number: 860439

Name: Z-2955-2026 Cardiac Workstation 5000. Product Number: 860439
Creator: Philips North America Llc
Published: 2026-07-01
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2026-07-01 / Open, Classified / root cause: software

FDA source

Philips North America Llc began a recall of Cardiac Workstation 5000. Product Number: 860439 on 2026-07-01. FDA classified it as Class II and gives the reason as "Device will intermittently provide inaccurate data related to native heart rate". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2955-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-01
Posted: 2026-08-14
Recalling firm: Philips North America LLC
Product: Cardiac Workstation 5000. Product Number: 860439.
Product code: DPS Electrocardiograph
Reason for recall: Device will intermittently provide inaccurate data related to native heart rate.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 796 units
Distribution: 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.
Product codes and lots: Product Number: 860439. UDI: (01)00884838094826. Serial Numbers: US42510185, US42510184, US52510209, US52510200, US52510226, US52510228, US62510247, US62510250, US62510256, US72510286, US82510299, US82510307, US82510300, US82510313, US82510318, US82510314, US82510335, US82510336, US82510341, US82510325, US92510351, US92510353, US92510354, US92510361, US92510362, US92510370, USN2510413, USN2510414, USN2510434, USN2510435, USN2510437, USD2510506, USD2510519, US12610582, USD2510513, US12610598, US22610609, US22610683, US22610691, US22610689, US32610737, US32610744, US32610759, US32610766, US32610749, US32610739, US32610751, USD2510516, USD2510510, USD2510517, USD2510529, USD2510509, US32610752, US32610753, US32610879, US32610880, US32610901, US32610914, US42610946, US32610915, US32610941, US32610932, US42610943, US42610942, US42610959, US42610958, US42610955, US42610974, US42610967, US42610956, US42610993, US42610960, CN72410032, CN92410061, CNO2410064, CNO2410068, CNN2410075, CND2410080, CND2410101, CND2410103, CN12510116, CN12510136, CN22510140, CN22510142, CN22510146, CN32510148, CN32510161, CN42510168, CN42510181, CN42510183, CN52510204, CN52510201, CN52510217, CN62510239, CN62510241, CN62510242, CN62510253, CN62510254, CN62510251, CN72510275, CN72510282, CN72510281, CN72510285, CN72510289, CN72510288, CN72510293, CN72510297, CN82510305, CN82510310, CN82510323, CN82510324, CN82510321, CN92510343, CN92510364, CN92510365, CN92510367, CN92510374, CNO2510380, CNO2510392, CNO2510383, CNO2510386, CNO2510396, CNN2510412, CNN2510410, CNN2510427, CNN2510443, CNN2510444, CNN2510454, CNN2510485, CNN2510486, CND2510503, CND2510502, CND2510508, CND2510528, CND2510530, CND2510566, CND2510575, CND2510574, CN12610585, CN12610590, CN12610595, CN12610593, CN22610612, CN22610681, CN22610707, CN22610735, CN32610755, CN32610760, CN32610761, CN32610762, CN32610763, CN32610765, CN32610818, CN32610826, CN32610910, CN32610913, CN32610912, CN32610924, CN32610923, CN32610929, CN32610930, CN32610933, CN42610944, CN42610951, CN42610970, US42610994

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2955-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2955-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14
Z-2956-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14

Product code DPS

K241556Class IICardiac Workstation (5000); Cardiac Workstation (7000)Philips Medizin Systeme Böblingen GmbH / cleared 2024-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)