Philips Cardiac Workstation 5000 and 7000
The Cardiac Workstation 5000 may provide inaccurate heart rate data.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Philips North America Llc, of Cambridge, Massachusetts, began a recall of the Cardiac Workstation 5000 and Cardiac Workstation 7000 on July 1, 2026, because the device will intermittently provide inaccurate data related to native heart rate. The FDA added the recall to its Enforcement Report and classified it on August 14, 2026, with the weekly report on August 26, 2026.
The products were distributed nationwide and worldwide, including countries such as Australia, Canada, France, Germany, and the United Kingdom.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI and product code listed under your product.
Cardiac Workstation 5000.
- UDI-DI
- 00884838094826
- Product code
- 860439.
Cardiac Workstation 7000.
- UDI-DI
- 00884838094833
- Product code
- 860441.
Details
- Company began the recall
- Sold in
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, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom.
- Event ID
- 99361
- Recall numbers
- Z-2955-2026 to Z-2956-2026
- Company
- Philips North America LlcCambridge, Massachusetts
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
