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Recall Observatory FDA recall evidence

Device product

Ultraview SL (UVSL) Command Module, Model 91496

Z-1503-2023

April 12, 2023

Class II

Product summary

Firm
Spacelabs Healthcare, Inc.
Event
Event 91851
Status
Ongoing
Classification
Class II
Quantity
1,088
Official record key
device-enforcement:Z-1503-2023

Official wording

Reason: 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.

Code information: Software version 2.03.06 and earlier and software version 2.04 and later.

Distribution pattern: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software version: 1) Older versions will