# FDA recall Z-0813-2022

> **Outset Medical, Inc.** · Class II · device recall initiated 2022-01-20.

## 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

- **Recall number:** Z-0813-2022
- **Recalling firm:** Outset Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0813-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0813-2022. Source: US FDA. Licensed CC0.

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