Recall Z-0332-2017— Spacelabs Healthcare Inc
Class II · Terminated
Class II FDA medical device recall by Spacelabs Healthcare Inc, initiated 2016-10-18, terminated 2017-04-03. It names one FDA 510(k) clearance: K122146. Product: Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.. Reason: The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally..
- Recalling firm
- Spacelabs Healthcare Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-18
- Terminated
- 2017-04-03
- 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
Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
Reason for recall
The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally.
Data sourced from openFDA. This site is unofficial and independent of the FDA.