Health product recall

Intesys Clinical Suite (ICS) G2 - Smart Disclosure (2019-02-04)

Starting date:
February 4, 2019
Posting date:
February 22, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69108

Affected Products

Intesys Clinical Suite (ICS) G2 - Smart Disclosure

Reason

Spacelabs has received reports of files being printed, either hardcopy or to pdf, with the correct patient demographics but containing the wrong patient waveforms. No one has been injured due to this issue.

Affected products

Intesys Clinical Suite (ICS) G2 - Smart Disclosure

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • 92810
Companies
Manufacturer
Spacelabs Healthcare Inc.
35301 SE Center Street
Snoqualmie
98065
Washington
UNITED STATES