Recall Z-2052-2026— Spacelabs Healthcare, Inc.
Class II · Ongoing
Class II FDA medical device recall by Spacelabs Healthcare, Inc., initiated 2026-03-26. It names one FDA 510(k) clearance: K103142. 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: Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester)..
- Recalling firm
- Spacelabs Healthcare, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-26
- Firm location
- Snoqualmie, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.