Outset Tablo Console Model PN-0003000 and PN-0006000: Heat Damage Risk
Outset Medical recalls two models of hemodialysis consoles (PN-0003000 and PN-0006000) due to a component that may cause heat-related damage. Affected units have specific serial numbers and UDI codes listed in the recall notice.
Lower-risk recall
Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.
Contact the company
What happened, in plain English
Outset Medical is recalling two models of hemodialysis consoles (PN-0003000 and PN-0006000) because a component in the device could cause heat-related damage. This risk is not expected to cause serious injury but may require attention to prevent potential damage. Read more at govinfonow.com/recall/61246-outset-tablo-console-model-pn-0003000-and-pn-0006000-heat.
Source Summary by GovInfoNow · govinfonow.com/recall/61246-outset-tablo-console-model-pn-0003000-and-pn-0006000-heat · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0813-2022
Cite this page
“Outset Tablo Console Model PN-0003000 and PN-0006000: Heat Damage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61246-outset-tablo-console-model-pn-0003000-and-pn-0006000-heat. Based on FDA recall #Z-0813-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0813-2022%22&limit=1).
Why it’s dangerous
A component in the hemodialysis console may overheat during normal use, potentially causing heat-related damage to the device. This could lead to malfunction or injury if not addressed, but the risk is not severe.
Who’s affected
Hemodialysis patients and healthcare providers who own or use the affected console models. The risk is low and not expected to cause serious injury.
How to tell if you have this one
Check for model numbers PN-0003000 or PN-0006000 on the console. Affected units also have specific serial numbers and UDI codes listed in the recall notice.
- Brand
Outset Medical- Product
Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000- Category
Medical device
What to do — step by step
Check Device Model
Look for model numbers PN-0003000 or PN-0006000 on the console.
Review Recall Details
Check the full list of affected serial numbers and UDI codes provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 46 states.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0813-2022 (January 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0813-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.