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
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 AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Software version 2.03.06 and earlier and software version 2.04 and later.
Where was it sold?
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.
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.
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