FDA recall record

Spacelabs Ultraview SL Command Module SL Command Module recall — FDA Z-2052-2026

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

Class IIclassification
Z-2052-2026official record ID
May 13, 2026report date

Recall record at a glance

Official recordZ-2052-2026
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmSpacelabs Healthcare, Inc.
Report dateMay 13, 2026
Recall initiation dateMar 26, 2026
Quantity57
LocationSnoqualmie, WA, United States

Official 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

Why the product was recalled

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

Distribution information

Worldwide - US Nationwide di GA, KS, MI, OH, SC, TX, WA and the country of ARGENTINA.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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