Recall Z-1705-2014— Spacelabs Healthcare Inc

Name: FDA recall Z-1705-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-08

Class II · Terminated

Class II FDA medical device recall by Spacelabs Healthcare Inc, initiated 2014-05-08, terminated 2014-06-03. It names one FDA 510(k) clearance: K103142. 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.. Reason: A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms..

Recalling firm: Spacelabs Healthcare Inc
Classification: Class II
Status: Terminated
Initiated: 2014-05-08
Terminated: 2014-06-03
Firm location: Snoqualmie, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K103142 — SPACELABS MULTI-PARAMETER MODULESpacelabs Healthcare, Inc.·cleared 2011-03-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.