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Spacelabs Healthcare Inc recalls Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Modu
Recalled June 11, 2014 · FDA recall Z-1705-2014 · Spacelabs Healthcare
Hazard
A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms. · FDA Class II
Units
64 devices
Sold at
US Distribution to GA.
Description
A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.
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.
Manufacturer(s)
Spacelabs Healthcare Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →