FDA-Device2023-05-10Class II
Ultraview SL (UVSL) Command Module, Model 91496
Spacelabs Healthcare, Inc.
Hazard
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.
Sold states
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.
Affected count
1,088
Manufactured in
35301 Se Center St, Snoqualmie, WA, United States
Products
Ultraview SL (UVSL) Command Module, Model 91496
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1503-2023Don't want to check this manually?
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