FDA Device recall Z-2955-2026
Cardiac Workstation 5000
- FDA Device
- Class II
- ongoing
- Published 2026-08-26
On 2026-08-26 the FDA classified a Class II recall of Cardiac Workstation 5000 by Philips North America, citing device will intermittently provide inaccurate data related to native heart rate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2955-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-01 |
| Published | 2026-08-26 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Cardiac Workstation 5000. Product Number: 860439.
Reason
Device will intermittently provide inaccurate data related to native heart rate.
Identifiers
| code_info | Product Number: 860439. UDI: (01)00884838094826. Serial Numbers: US42510185, US42510184, US52510209, US52510200, US5251…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2955-2026%22
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