Date Initiated by Firm |
May 08, 2014 |
Date Posted |
June 03, 2014 |
Recall Status1 |
Terminated 3 on June 03, 2014 |
Recall Number |
Z-1705-2014 |
Recall Event ID |
68357 |
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 WA 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 |
Software Manufacturing/Software Deployment |
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
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = DSI and Original Applicant = SPACELABS HEALTHCARE, INC.
|