Recall Z-2955-2026— Philips North America Llc

Name: FDA recall Z-2955-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-01

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2026-07-01. It names one FDA 510(k) clearance: K241556. Product: Cardiac Workstation 5000. Product Number: 860439.. Reason: Device will intermittently provide inaccurate data related to native heart rate..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2026-07-01
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000)Philips Medizin Systeme Böblingen GmbH·cleared 2024-12-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Cardiac Workstation 5000. Product Number: 860439.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.