11

Jun

2014

Spacelabs Medical Ultraview SL” Command Mod Cl II

0

Company: Spacelabs Healthcare Inc
Date of Enforcement Report:6/11/2014
Class lI:

PRODUCT

Spacelabs Medical Ultraview SL” Command Module, Model 91496. Detector and alarm, arrhythmia. 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 Number Z-1705-2014

REASON
A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms..

RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare Inc., Snoqualmie WA on 5/8/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
64 devices p>

DISTRIBUTION
US Distribution to GA

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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