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FDAJanuary 28, 2019device

Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.

What to do

FDA enforcement status: Terminated

Brands named

spacelabs healthcarespacelabs

UPCs

10841522123580

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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