Recall Z-2261-2020— Spacelabs Healthcare, Inc.

Name: FDA recall Z-2261-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-30

Class II · Terminated

Class II FDA medical device recall by Spacelabs Healthcare, Inc., initiated 2019-08-30, terminated 2024-04-18. It names one FDA 510(k) clearance: K122146. Product: Xhibit Central, Model No. 96102 - Product Usage: 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 loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition..

Recalling firm: Spacelabs Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-08-30
Terminated: 2024-04-18
Firm location: Snoqualmie, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K122146 — XHIBIT CENTRAL STATION, MODEL 96102Spacelabs Healthcare·cleared 2013-04-22

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

Xhibit Central, Model No. 96102 - Product Usage: 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 loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.

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