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Spacelabs Healthcare, Inc. recalls Ultraview SL (UVSL) Command Module, Model 91496
Recalled May 10, 2023 · FDA recall Z-1503-2023 · Spacelabs Healthcare
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. · FDA Class II
Units
1,088
Sold at
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.
Description
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.
Product
Ultraview SL (UVSL) Command Module, Model 91496
Manufacturer(s)
Spacelabs Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →