Cardiac Workstation 7000 recalled due to pinched power module wire
Philips is recalling 29 units of the Cardiac Workstation 7000 due to a pinched power module wire inside the device housing that can cause an electrical short.
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: This is a Class II recall involving a risk-of-harm medical device where a pinched power wire can cause an electrical short. Although no injuries or hospitalizations have been reported, the defect poses a potential risk to device functionality and safety.
Plain-English summary
Philips North America is recalling 29 units of the Cardiac Workstation 7000 (Model 860441) nationwide. During environmental stress testing, the manufacturer identified a design defect involving a pinched power module wire within the device housing. This defect can result in an electrical short.
The affected units were distributed in California, Iowa, Tennessee, Texas, and Virginia. The affected serial numbers are US42520284, US32520248, US32520244, US22520238, and US22520221.
Healthcare facilities and clinicians using affected Cardiac Workstation 7000 devices should discontinue use immediately and contact Philips North America. The electrical short poses a potential risk of device malfunction and electrical hazard. Customers should return affected devices to Philips for repair or replacement.
The recalled product
- Product
- Cardiac Workstation 7000; Model Number: 860441;
- Manufacturer
- Philips North America
- Category
- Medical Device — Cardiac imaging
- Hazard
- electrical-short
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 (7)
- Model Number: 860441
- UDI-DI: 00884838094833
- Serial Numbers: US42520284
- US32520248
- US32520244
- US22520238
- US22520221
Distribution
Distributed nationwide across the United States.
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