FDA-Device2014-02-05Class II
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
Spacelabs Healthcare, Llc
Hazard
The AriaTele Model 96281 with SpO2 monitoring Option C is recalled because the AriaTele (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.
Sold states
Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, GA, IA, IL, LA, MA, ME, MI, MO, MS, NY, PA, SC, TN, TX, VA, and Puerto Rico; and Internationally to: Canada, Chile, and Panama.
Affected count
1057 units (988 in the US and 69 outside of the US).
Manufactured in
35301 Se Center St, Snoqualmie, WA, United States
Products
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0871-2014Don't want to check this manually?
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