Company:Spacelabs Healthcare Inc.
Date of Enforcement Report: 3/4/2015
Class lI:
PRODUCT
Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.
Recall Number Z-1144-2015
REASON
Spacelabs Healthcare XPREZZON Bedside Monitors, Model 91393, are recalled because the firm has received multiple reports of XPREZZON monitors failing to boot up or returning to factory default configuration settings following power on or reset..
RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare Inc., Snoqualmie, WA on 1/28/2015 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
total 1578 units (702 units in the US and 876 outside US)
DISTRIBUTION
Worldwide
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