Device product
Ultraview SL (UVSL) Command Module, Model 91496
Z-1503-2023
Product summary
- 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
software version: 1) Older versions will