Recall Z-0813-2022— Outset Medical, Inc.

Name: FDA recall Z-0813-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-20

Class II · Ongoing

Class II FDA medical device recall by Outset Medical, Inc., initiated 2022-01-20. It names 2 FDA 510(k) clearances: K200741, K190793. Product: Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000. Reason: Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device..

Recalling firm: Outset Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-01-20
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K200741 — Tablo Hemodialysis SystemOutset Medical, Inc.·cleared 2020-03-31
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 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.

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