Spacelabs Healthcare, Inc. recalls Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Mod…

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

On 03/26/2026, the firm sent via email an URGENT MEDICAL DEVICE CORRECTION Letter to customers informing them that Spacelabs Healthcare became aware that for certain Multi-Parameter Command Modules (Model 91496) manufactured between 07/17/2025 to 08/05/2026 using a malfunctioning test equipment resulting in inadequate electrical leakage testing. Customers are instructed to: 1.Notify Please notify all relevant employees within your organization, including facilities you have distributed the products to, of this medical device correction notice and to cease use of the modules identified in Appendix B. 2.Acknowledge Please acknowledge receipt of this notice by either utilizing the URL/QR code listed in Appendix A or completing the paper acknowledgement form and returning it via one of the methods outlined in the form. 3.Segregate Identify and Quarantine the affected devices listed in Appendix B. 4.Report Contact your local Spacelabs Healthcare service representative to coordinate your device correction as soon as possible. To remedy the issue identified in this letter, Spacelabs Healthcare will be replacing the impacted devices with brand new units of the same specification. For questions - call Phone: 1-800-522-7025 Website: https://spacelabshealthcare.com/support/

• FDA enforcement recordOfficial FDA database entry for Z-2052-2026
• FDA 510(k) clearance · K103142The device's official FDA premarket clearance record
• FDA device classification · DSIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1025The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Spacelabs Healthcare, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.