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.
This recall has been terminated (originally issued January 17, 2012).
- Company
- Spacelabs Healthcare, Llc
- Recall Initiated
- July 13, 2011
- Posted
- January 17, 2012
- Terminated
- January 20, 2012
- Recall Number
- Z-0776-2012
- Quantity
- one unit
- Firm Location
- Issaquah, WA
- Official Source
- View on FDA website ↗
Reason for Recall
One Spacelabs Medical Ultraview SL Command Module, Model 91496, was removed from customer due to software error.
Distribution
One device distributed in Troy, MI.
Lot / Code Info
Serial number: 1496-029792
Root Cause
Software design
Action Taken
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.
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