Medical device recalls Moderate risk

Spacelabs Healthcare, Inc. recalls Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software…

Recall date
March 26, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2052-2026
FDA classification
Class II
Brand / firm
Spacelabs Healthcare, Inc.
Sold / distributed
Worldwide - US Nationwide di GA, KS, MI, OH, SC, TX, WA and the country of ARGENTINA.

Why it was recalled

Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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