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U.S. Department of Health and Human Services

Class 2 Device Recall Ultraview SL Command Module

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 Class 2 Recall
Ultraview SL Command Module
see related information
Date Posted June 03, 2014
Recall Status1 Terminated on June 03, 2014
Recall Number Z-1705-2014
Recall Event ID 68357
Premarket Notification
510(K) Number
K103142 
Product Classification Detector And Alarm, Arrhythmia - Product Code DSI
Product Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from a patient in a clinical environment.
Code Information All devices of Model: 91496.
Recalling Firm/
Manufacturer
Spacelabs Healthcare Inc
35301 SE Center St
Snoqualmie, Washington 98065-9216
For Additional Information Contact Al Van Houdt
425-657-7200 Ext. 5970
Manufacturer Reason
for Recall
A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.
FDA Determined
Cause 2
DESIGN: Software Design
Action Spacelabs Healthcare identified a software anomaly in the Ultraview SL" Command Module, Model 91496. During an internal audit, Spacelabs identified a reportable recall that was not reported. We have a product called the Spacelabs Medical Ultraview SL" Command Module, Model 91496. A software error was discovered at a customer site which was not a safety issue, but in the interest of customer service it was decided to downgrade all their modules with an older software version.
Quantity in Commerce 64 devices
Distribution US Distribution to GA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DSI and Original Applicant = SPACELABS HEALTHCARE, INC.
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