Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software V

FDA device recall Z-2052-2026 · posted 2026-05-01 · Open, Classified

Recall details

Recalling firm

Spacelabs Healthcare, Inc.

Reason for recall

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

Action taken

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/

Root cause

Process control

Status

Open, Classified

Product code

DSI

Quantity affected

57

Distribution

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

Date initiated

2026-03-26

Date posted

2026-05-01

Location

Snoqualmie, WA

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