FDA-Device2014-09-10Class II
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
Spacelabs Healthcare Inc
Hazard
The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of recall Z-0871-2014 because additional serial numbers were identified as being part of this recall action as part of the firm's retrospective analysis of all recalls since 2011.
Sold states
US Distribution to TX.
Affected count
8 units
Manufactured in
35301 SE Center St, Snoqualmie, WA, United States
Products
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2586-2014Don't want to check this manually?
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