Class II U.S. Food and Drug Administration

Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL recall: Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage

Recall published 6 months ago

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

The hazard: Device malfunction

This is a device recall, and in FDA language that usually means a correction rather than a removal: the device stays in use and the manufacturer fixes, patches or re-instructs.

What the notice says: Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).

Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.

Symptoms and when to call a doctor

If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2052-2026
Published
May 13, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Spacelabs Healthcare, Inc.
Product type
Medical devices
Units affected
57
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
10841522106422

Products covered by this recall

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

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10841522106422

Model or item number

On the rating label, the box or the instruction sheet.

  • 91496 Software Version

Serial number

On the rating plate, often next to the date of manufacture.

  • 1496-224669 1496-224670 1496-224657 1496

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Malfunction

Spacelabs Healthcare, Inc. — This is a device recall, and in FDA language that usually means a correction rather than a removal: the device stays in use and the manufacturer fixes, patches or re-instructs.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. Check whether the remedy is a software update, and if so confirm afterwards in the device menu that the version actually changed.
  3. If you are a clinic or facility, quarantine affected stock and record the correction in your recall log.
  4. Report device problems to the FDA through MedWatch — that database is where this recall came from.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Spacelabs Healthcare, Inc. — 35301 Se Center St, Snoqualmie, WA, 98065-9216

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Spacelabs Healthcare, Inc. medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10841522106422; model number 91496 Software Version. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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