[pending] Cardiac Workstation 5000; Model Number: 860439;
Pending LLM rewrite. Source: FDA_DEVICE Z-0165-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
The recalled product
- Product
- Cardiac Workstation 5000; Model Number: 860439;
- Manufacturer
- Philips North America
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Number: 860439
- UDI-DI: 00884838094826
- Serial Numbers:
Distribution
Distributed nationwide across the United States.
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