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
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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.
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510(K) Database | 510(K)s with Product Code = DSI
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