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