RecallDepth

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.

Company
Spacelabs Healthcare, Inc.
Recall Initiated
May 8, 2014
Posted
June 3, 2014
Terminated
June 3, 2014
Recall Number
Z-1705-2014
Quantity
64 devices
Firm Location
Snoqualmie, WA

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.

Distribution

US Distribution to GA.

Lot / Code Info

All devices of Model: 91496.

Root Cause

Software Manufacturing/Software Deployment

Action Taken

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.

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