Recall Z-2586-2014— Spacelabs Healthcare Inc
Class II · Terminated
Class II FDA medical device recall by Spacelabs Healthcare Inc, initiated 2014-07-02, terminated 2014-10-16. It names one FDA 510(k) clearance: K121480. Product: ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.. 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..
- Recalling firm
- Spacelabs Healthcare Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-02
- Terminated
- 2014-10-16
- Firm location
- Snoqualmie, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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. Physiological patient monitor. Used in a hospital environment.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.