# FDA recall Z-2955-2026

> **Philips North America Llc** · Class II · device recall initiated 2026-07-01.

## Product

Cardiac Workstation 5000. Product Number: 860439.

## Reason for recall

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

## 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, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-2955-2026
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-01
- **Report date:** 2026-08-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2955-2026

## Citation

> MORVS. FDA recall Z-2955-2026. Retrieved 2026-10-19 from https://api.morvs.ai/recall/Z-2955-2026. Source: US FDA. Licensed CC0.

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