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.
FDA Recall Z-1705-2014 · Posted 2014-06-03
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Recalling FirmSpacelabs Healthcare Inc
Recall StatusTerminated
Product CodeDSI
Date Initiated2014-05-08
Date Terminated2014-06-03
Product Quantity64 devices
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.
Firm 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.
Root Cause
Software Manufacturing/Software Deployment
Distribution Pattern
US Distribution to GA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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