Cardiac Workstation 7000 recalled after pinched power module wire caused short
Philips is recalling 29 Cardiac Workstation 7000 units after environmental stress testing failed because a pinched power module wire inside the housing resulted in a 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: Scored 3 under the risk-of-harm criterion: a shorted power module inside a clinical workstation is an electrical hazard, and no injuries are reported.
Plain-English summary
The Cardiac Workstation 7000, model number 860441, is being recalled.
The device failed environmental stress testing because of a pinched power module wire within the housing of the workstation, which resulted in a short.
The recall covers 29 units carrying UDI-DI 00884838094833, with serial numbers including US42520284, US32520248, US32520244 and US22520238. The product was distributed in California, Iowa, Tennessee, Texas and Virginia. The FDA has classified the action as Class II.
The enforcement record describes the test failure and reports no injuries. Facilities operating affected serial numbers should follow Philips' instructions.
The recalled product
- Product
- Cardiac Workstation 7000; Model Number: 860441;
- Manufacturer
- Philips North America
- Affected units
- 29
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
Part of a larger recall action
This product is one of 2 recalled by Philips North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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