Company: Spacelabs Healthcare, Inc.
Date of Enforcement Report: 7/31/2019
Class II

PRODUCT

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

Recall Number: Z-2035-2019

REASON

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

RECALLING FIRM/MANUFACTURER

Spacelabs Healthcare, Inc. on 1/28/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
295 customer sites have the affected software versions

DISTRIBUTION

US Nationwide (including government/military) and International