Spacelabs Medical Ultraview SL Command Module, Model 91496. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.
FDA Recall Z-0776-2012 · Posted 2012-01-17
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Recalling FirmSpacelabs Healthcare, Llc
Recall StatusTerminated
Product CodeDSI
Date Initiated2011-07-13
Date Terminated2012-01-20
Product Quantityone unit
Reason for Recall
One Spacelabs Medical Ultraview SL Command Module, Model 91496, was removed from customer due to software error.
Firm Action
Spacelabs removed one affected unit of Medical Ultraview SL Command Module from a hospital in Troy, MI. during a site visit on July 13, 2011. This recall pertains to one single unit at one location. Contact Spacelabs at 425-657-7200 for questions regarding this recall.
Root Cause
Software design
Distribution Pattern
One device distributed in Troy, MI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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