Recall Z-2955-2026 · DPS Electrocardiograph
Philips North America Llc
Cardiac Workstation 5000. Product Number: 860439.
| Date | Aug 14, 2026 (initiated Jul 1, 2026) |
| Status | Open, Classified |
| Reason | Device will intermittently provide inaccurate data related to native heart rate. |
| Root cause | Software design |
| Action | Philips notified consignees on about 07/01/2026 via URGENT Medical Device Correction letter. Consignees were informed that they could continue the use of the device but to refer to the information within the notification letter, disable the automatic Standby feature on the Cardiac Workstation and avoid manually putting the Cardiac Workstation in Standby mode to minimize the inaccurate heart rate value from occurring, and to pass the notice to all those who need to be aware within each organization or to any organization where affected product(s) have been potentially transferred. Additiona |
| Quantity | 796 units |
| 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, Pol |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000) Philips Medizin Systeme Böblingen GmbH, Dec 17, 2024 |