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Terminated

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

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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