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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

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