Cardiac Workstation recallZ-2955-2026 · Philips North America Llc · initiated Jul 1, 2026

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Device will intermittently provide inaccurate data related to native heart rate.

FDA root cause category: Software design

What the company 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.

Recall details

Recall number: Z-2955-2026
Status: Open, Classified
Initiated by the company: Jul 1, 2026
Posted by the FDA: Aug 14, 2026
Recalling firm: Philips North America Llc
Quantity: 796 units
Product code: DPS
FDA submissions: K241556
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 description

Cardiac Workstation 5000. Product Number: 860439.

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Cardiac Workstation Cardiac Workstation 5000
Philips Medizin Systeme Böblingen GmbH · Electrocardiograph
2 recalls1 report

Product lines

Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbH · 2 models · 18 reports · 4 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 99361).

Z-2956-2026 · Open, Classified
Cardiac Workstation 7000. Product Number: 860441.

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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