Company: Spacelab Healthcare, Inc.
Date of Enforcement Report 3/16/2016
Class lI:
PRODUCT
Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. Recall Number Z-1092-2016
REASON
The firm has received one report of values for patient height and weight being switched when input at the Xhibit Central Station, Model 96102, causing a bedside monitor Body Surface Area (BSA) calculation to be in error.
RECALLING FIRM/MANUFACTURER
Spacelab Healthcare, Inc., Snoqualmie, WA on 3/10/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1075
DISTRIBUTION
Nationwide and Internationally
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