Warning
Spacelabs Healthcare Recalls Brand Name: Spacelabs Ultraview SL Command Module.
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2052-2026Medical Device
Spacelabs Healthcare Recalls Brand Name: Spacelabs Ultraview SL Command Module.
Spacelabs Healthcare, Inc. · Class II — Moderate Risk
Product Description
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital. Component: N/A
Reason for Recall
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Worldwide - US Nationwide di GA, KS, MI, OH, SC, TX, WA and the country of ARGENTINA.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database