Class II — Philips North America Llc
| Recalling firm | Philips North America Llc |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | Device will intermittently provide inaccurate data related to native heart rate. |
| Product | Cardiac Workstation 7000. Product Number: 860441. |
| Quantity | 1,810 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, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Spain, Swede… |
| Initiated | 2026-07-01 |
| Classified | 2026-08-14 |
| Recall number | Z-2956-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Philips North America Llc (Z-2956-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99361/
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