Summary
The FDA issued a Class II for Cardiac Workstation 5000. Product Number: 860439. by Philips North America Llc. Reason: Device will intermittently provide inaccurate data related to native heart rate..
Details
Source
Device Recall
External ID
Z-2955-2026
Action Date
2026-08-26
Status
Ongoing
Category
device
Product Description
Cardiac Workstation 5000. Product Number: 860439.
Lot/Code Info: 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
Quantity Affected: 796 units
Reason for Recall
Device will intermittently provide inaccurate data related to native heart rate.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-01
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Philips North America Llc has 283 FDA actions in our database, including 283 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America Llc have FDA actions?
Philips North America Llc has 283 FDA actions in our database, including 283 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2955-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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