Cardiac workstations recalled after pinched power module wire caused short
Philips is recalling 28 Cardiac Workstation 5000 units after environmental stress testing failed because a pinched power module wire inside the housing resulted in a short.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 5000, model number 860439, 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 28 units carrying UDI-DI 00884838094826, 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 5000; Model Number: 860439;
- Manufacturer
- Philips North America
- Affected units
- 28
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
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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