Company:Spacelabs Healthcare, LLC
Date of Enforcement Report 2/22/12
Class ll:
PRODUCT
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. Recall # Z-0776-2012
REASON
Due to software error..
RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare, LLC, Issaquah, WA, by visit on July 13, 2011. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI