medical Class II Updated 2019-07-31

Spacelabs Healthcare, Inc. recalls Spacelabs Healthcare Smart Disclosure System, Model 92810, a

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All affected Smart Disclosure installations with software versions 5.00, 5.01, 5.02, or 5.03, UDI 10841522123580.
View official government recall

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