FDA recall Z-2052-2026

Product

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).

Distribution

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

Key facts

Status

Ongoing

Initiation date

2026-03-26

Report date

2026-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Snoqualmie, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2052-2026