Recall Z-1351-2023— Outset Medical, Inc.

Name: FDA recall Z-1351-2023
Creator: U.S. Food and Drug Administration
Published: 2023-01-24

Class II · Ongoing

Class II FDA medical device recall by Outset Medical, Inc., initiated 2023-01-24. It names 2 FDA 510(k) clearances: K211370, K190793. 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.. 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: Outset Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-01-24
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K211370 — Tablo Hemodialysis SystemOutset Medical, Inc.·cleared 2022-07-29
K190793 — Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc.·cleared 2019-12-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.