Company: Outset Medical, Inc.
Date of Enforcement Report: 4/07/2023
Class II

PRODUCT

Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility.

Recall Number:

Z-1351-2023

REASON:

An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.

RECALLING FIRM/MANUFACTURER:

Outset Medical, Inc

VOLUME OF PRODUCT IN COMMERCE:

374 systems

DISTRIBUTION:

U.S. Nationwide distribution including in the states of AK, AL, AR, CA, CO, FL, GA, HI, IA, ID, IL, IN, MI, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, and WI. O.U.S.: Not provided.