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Rappel de produits de santé

Ultraview Digital Telemetry System and Accessories (2016-04-05)

Starting date:
April 5, 2016
Posting date:
April 22, 2016
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-58006

Affected products

A. Ultraview Digital Telemetry System and Accessories

Reason

Spacelabs has received multiple complaints reporting an abnormally high frequency of "squelch" events on Xhibit Telemetry Receivers (XTR), which is indicative of the loss of the telemetry data signal. In some cases, the Xhibit central monitor was also reported to display an "Xhibit offline" error message for all patients being monitored. No one has been injured due to this issue.

Affected products

A. Ultraview Digital Telemetry System and Accessories

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

96280

Companies
Manufacturer
Spacelabs Healthcare Inc.
35301 SE Center Street
Snoqualmie
98065
UNITED STATES