Ultraview SL recallZ-2052-2026 · Spacelabs Healthcare, Inc. · initiated Mar 26, 2026

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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/

Recall details

Recall number

Z-2052-2026

Status

Open, Classified

Initiated by the company

Mar 26, 2026

Posted by the FDA

May 1, 2026

Recalling firm

Spacelabs Healthcare, Inc.

Quantity

57

Product code

DSI

FDA submissions

K103142

Distribution

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

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Ultraview SL Ultraview SL®

  Spacelabs Healthcare (Washington), Inc · SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
  2 recalls2 reports

Product lines

• Ultraview SLSpacelabs Healthcare (Washington), Inc · 2 models · 5 reports · 2 recalls

Other devices under the same FDA submission

1 device cleared under K103142 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Ultraview SL UV SL Command Module

  Spacelabs Healthcare (Washington), Inc · DETECTOR AND ALARM, ARRHYTHMIA
  1 recall3 reports