FDA recall Z-1503-2023

Product

Ultraview SL (UVSL) Command Module, Model 91496

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.

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2023-04-12

Report date

2023-05-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Snoqualmie, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1503-2023