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Spacelabs Healthcare Inc recalls ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital env

Recalled September 10, 2014 · FDA recall Z-2586-2014 · Spacelabs Healthcare

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. · FDA Class II
Units
8 units
Sold at
US Distribution to TX.

Description

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.

Product
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
Manufacturer(s)
Spacelabs Healthcare Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov