Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1542-2015 — Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant

U.S. FDA — Device Enforcement · United States · 2015-04-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1542-2015
Date of alert
2015-04-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Spacelabs Healthcare Inc
Product category
device
Product type
Devices
Reported risk: Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Customer reported that during the time that the module is resetting (~10 seconds), monitoring of all parameters will be suspended. Upon completion of this sequence, alarms will be reset to their default values.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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