CLASS II ONGOING Device recall · Reported 10 May 2023 · FDA Enforcement Report

Ultraview SL (UVSL) Command Module recalled by Spacelabs Healthcare

Spacelabs Healthcare is recalling Ultraview SL (UVSL) Command Module, distributed nationwide in the US. The recall was initiated on 12 Apr 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware version 2.03.06 and earlier and software version 2.04 and later.

Quantity recalled1,088

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-1503-2023
FDA event ID: 91851
Recalling firm: Spacelabs Healthcare, Snoqualmie, WA
Classification: Class II
Status: Ongoing
Recall initiated: 12 Apr 2023
FDA classified: 3 May 2023
Reported: 10 May 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

12 Apr 2023	Recall initiated by company
3 May 2023	Classified by FDA	+21 days
10 May 2023	Published in enforcement report	+7 days

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

Reason for recall

Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) Newer versions have waveforms absent with no alarms. This may cause clinicians to miss a potentially catastrophic event.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Ultraview SL (UVSL) Command Module, Model 91496

Where it was distributed

US Nationwide distribution in the states of SD, KY, MO, WA, OH, NC, CA, OR, TX, GA, IL, OK, SC, PA, AL, KS, FL, ID, MI, MN, IA, NJ, MD, VA, AR, CT, NE, LA, AK, MS, ME, WV, NY, AZ, TN, WY, IN, MA, MT, CO, DE, ND, WI, NV, RI, NH, UT.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine

Questions about this recall

Is Ultraview SL (UVSL) Command Module recalled?

Yes. Spacelabs Healthcare recalled Ultraview SL (UVSL) Command Module on 12 Apr 2023. The recall is Class II and its status is Ongoing. Recall number Z-1503-2023.

Why was it recalled?

Which lots are affected?

Software version 2.03.06 and earlier and software version 2.04 and later.

Where was it sold?

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 21 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

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19 Aug 2026Device	CLASS II	Xhibit Central Station recalled by Spacelabs Healthcare	Spacelabs Healthcare	Device Malfunction	Nationwide
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15 Apr 2026Device	CLASS II	Multi-parameter Command Module recalled by Spacelabs Healthcare	Spacelabs Healthcare	Labeling Errors	Nationwide
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