CLASS II ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report

Spacelabs Ultraview SL Command Module SL Command Module recalled

Spacelabs Healthcare is recalling Spacelabs Ultraview SL Command Module SL Command Module, distributed nationwide in the US. The recall was initiated on 26 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/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

Quantity recalled57

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2052-2026
FDA event ID: 98722
Recalling firm: Spacelabs Healthcare, Snoqualmie, WA
Classification: Class II
Status: Ongoing
Recall initiated: 26 Mar 2026
FDA classified: 1 May 2026
Reported: 13 May 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Patient Monitors

Timeline

26 Mar 2026	Recall initiated by company
1 May 2026	Classified by FDA	+36 days
13 May 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Georgia Kansas Michigan Ohio South Carolina Texas Washington

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Spacelabs Healthcare

All 47

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	Xhibit Central Station recalled by Spacelabs Healthcare	Spacelabs Healthcare	Device Malfunction	Nationwide
15 Apr 2026Device	CLASS II	Multi-parameter Command Module recalled by Spacelabs Healthcare	Spacelabs Healthcare	Labeling Errors	Nationwide
12 Nov 2025Device	CLASS II	Sentinel V11 recalled by Spacelabs Healthcare	Spacelabs Healthcare	Device Malfunction	Nationwide
22 Oct 2025Device	CLASS II	Branding is not applied to this product DVI display cables recalled	Spacelabs Healthcare	Device Malfunction	Nationwide
22 Oct 2025Device	CLASS II	Branding is not applied to this product DVI display cables recalled	Spacelabs Healthcare	Device Malfunction	Nationwide

Other Patient Monitors recalls

All 1,014

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	nGenuity Patient Monitor with Capnography recalled	Criticare Technologies	Device Malfunction	Nationwide
16 Sep 2026Device	CLASS I	Bravo CF capsule delivery device, Product Number FGS recalled	Given Imaging	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide