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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