Device product
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
Z-2586-2014
Product summary
- Event
- Event 69125
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-2586-2014
Official wording
Reason: 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.
Code information: Serial numbers: 6281-002500, 6281-002501, 6281-002659, 6281-002661, 6281-002662, 6281-002663, 6281-002664, and 6281-003056. Model 96281, with SpO2 Option C.
Distribution pattern: US Distribution to TX.
Derived failure modes
-
Unknown
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.