Cardiac Workstation 5000. Product Number: 860439.
FDA device recall Z-2955-2026 · posted 2026-08-14 · Open, Classified
Recall details
- Recalling firm
- Philips North America Llc
- Reason for recall
- Device will intermittently provide inaccurate data related to native heart rate.
- Action taken
- 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. Additionally, consignees were requested to place the Urgent Medical Device Correction letter with the documentation of the Cardiac Workstation and associated devices in a place where it is most likely to be seen and viewed. Philips representatives will contact consignees to arrange an upgrade to the Cardiac Workstation Release 1.2.0.7.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- DPS
- Quantity affected
- 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, Ic
- Date initiated
- 2026-07-01
- Date posted
- 2026-08-14
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Cardiac Workstation (5000); Cardiac Workstation (7000) (K241556) | Philips Medizin Systeme Böblingen GmbH | 2024-12-17 |