Z-2955-2026 Class II Ongoing
FDA device recall Z-2955-2026 was initiated by Philips North America Llc on July 1, 2026 and is designated Class II. Reason for recall: Device will intermittently provide inaccurate data related to native heart rate. The recall status is ongoing. Affected quantity: 796 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2026
- Initiation Date
- July 1, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 796 units
Product Description
Cardiac Workstation 5000. Product Number: 860439.
Reason for Recall
Device will intermittently provide inaccurate data related to native heart rate.
Distribution Pattern
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.
Code Information
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