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# Outset Medical Gets Tablo Warning Letter
- URL: https://www.fdaweb.com/outset-medical-gets-tablo-warning-letter/
- Published: 2023-07-10T12:00:00.000Z
- Updated: 2026-09-14T18:42:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154838

Outset Medical says FDA sent it a 7/5 Warning Letter with six observations from a 2/10 inspection involving the firm’s Tablo Hemodialysis System. Outset released the information in a Securities and Exchange Commission [filing](https://www.sec.gov/ix?doc=/Archives/edgar/data/1484612/000119312523183869/d511727d8k.htm&ref=fdaweb.com).

The company says the letter does not request any restriction on the manufacture, production, or shipment of the system and does not ask Outset to withdraw the system from the U.S. market. Outset says it will fully cooperate with FDA on this matter.