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