Recall – Patient monitoring system printed incorrect patient results

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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.