FDA recall Z-0813-2022

Outset Medical, Inc. · Class II · device

Product

Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000

Reason for recall

Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.

Distribution

U.S. Nationwide distribution in the states of AL, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NY, NM, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY.

Key facts

Status: Ongoing
Initiation date: 2022-01-20
Report date: 2022-03-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: San Jose, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0813-2022