Recall Z-0871-2014— Spacelabs Healthcare, Llc

Name: FDA recall Z-0871-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-19

Class II · Terminated

Class II FDA medical device recall by Spacelabs Healthcare, Llc, initiated 2013-12-19, terminated 2014-06-12. It names one FDA 510(k) clearance: K121480. Product: 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.. Reason: 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..

Recalling firm: Spacelabs Healthcare, Llc
Classification: Class II
Status: Terminated
Initiated: 2013-12-19
Terminated: 2014-06-12
Firm location: Snoqualmie, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K121480 — ARIATELE TELEMETRY TRANSMITTER (96281)Spacelabs Healthcare·cleared 2012-06-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.