FDA Medical devices recall ·
Cardiac Workstation 7000 recall
- Recall number
- Z-0166-2026
- Date
- (initiated September 12, 2025)
- Company / brand
- Philips North America Llc
222 Jacobs St, Cambridge, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 29 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Cardiac Workstation 7000; Model Number: 860441;
Why was it recalled?
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 860441; UDI-DI: 00884838094833; Serial Numbers: US42520284, US32520248, US32520244, US22520238, US22520221;
Distribution
US Nationwide distribution in the states of CA, IA, TN, TX, VA.
States: California Iowa Tennessee Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0166-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.