Philips North America Llc
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Device will intermittently provide inaccurate data related to native heart rate.
Cardiac Workstation 5000. Product Number: 860439.
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
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →