Spacelabs Healthcare, Inc.: 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

Recall number

Z-2052-2026

Recalling firm

Spacelabs Healthcare, Inc.

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

Status

Open, Classified

Initiated

2026-03-26

Posted

2026-05-01

Terminated

not on file

Reason

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

Root cause

Process control

Action

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/

Quantity

57

Distribution

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

Lot, serial or model codes

Model/Catalog Number: 91496 UDI-DI Code: (01)10841522106422 Serial Numbers: 1496-224669 1496-224670 1496-224657 1496-224658 1496-224659 1496-224660 1496-224661 1496-224671 1496-224673 1496-224674 1496-224675 1496-224676 1496-224677 1496-224678 1496-224679 1496-224680 1496-224681 1496-224682 1496-224683 1496-224684 1496-224685 1496-224686 1496-224687 1496-224688 1496-224689 1496-224690 1496-224691 1496-224692 1496-224693 1496-224694 1496-224695 1496-224696 1496-224697 1496-224698 1496-224699 1496-224701 1496-224702 1496-224703 1496-224704 1496-224705 1496-224706 1496-224707 1496-224708 1496-224709 1496-224710 1496-224711 1496-224712 1496-224713 1496-224714 1496-224715 1496-224716 1496-224664 1496-224665 1496-224666 1496-224667 1496-224668

510(k) numbers

K103142

PMA numbers

not on file

Product code

DSI

Firm FEI

3010157426

Firm city

Snoqualmie

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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