Outset Tablo Hemodialysis System Recall: High Conductivity Dialysate Alarms
Outset Medical recalls Tablo hemodialysis systems (model PN-0006000, PN-0007001) due to high conductivity dialysate alarms from software changes. Affected units have specific serial numbers.
Lower-risk 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.
Contact the company
What happened, in plain English
Outset Medical is recalling Tablo hemodialysis systems with model numbers PN-0006000 and PN-0007001 because software changes during manufacturing caused high conductivity dialysate alarms. This could lead to incorrect dialysis treatment if not addressed. Read more at govinfonow.com/recall/59017-outset-tablo-hemodialysis-system-recall-high-conductivity-dialysate-alarms.
Source Summary by GovInfoNow · govinfonow.com/recall/59017-outset-tablo-hemodialysis-system-recall-high-conductivity-dialysate-alarms · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1351-2023
Cite this page
“Outset Tablo Hemodialysis System Recall: High Conductivity Dialysate Alarms.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59017-outset-tablo-hemodialysis-system-recall-high-conductivity-dialysate-alarms. Based on FDA recall #Z-1351-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1351-2023%22&limit=1).
Why it’s dangerous
The software change introduced during manufacturing caused the dialysate to show higher conductivity levels than expected. This could lead to incorrect dialysis treatment if the alarms are not properly managed.
Who’s affected
Home dialysis patients using the Tablo system with model numbers PN-0006000 or PN-0007001 are affected. Patients using the system without proper monitoring may be at slightly higher risk.
How to tell if you have this one
Check for model numbers PN-0006000 or PN-0007001 on the device. Affected units have specific serial numbers listed in the recall notice.
- Brand
Outset- Category
Medical device
What to do — step by step
Check Device Model
Look for model numbers PN-0006000 or PN-0007001 on the Tablo device.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 33 states.
FDA distribution: “U.S. Nationwide distribution including in the states of AK, AL, AR, CA, CO, FL, GA, HI, IA, ID, IL, IN, MI, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, and WI. O.U.S.: Not provided.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Wisconsin.
Recall timeline
FDA published this recall 3 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.
Questions people ask
What should I do if I have this device?
Check the device model and serial numbers against the list provided in the recall notice. If affected, contact Outset Medical for further instructions.
Is there a risk of serious injury?
The recall indicates a potential for incorrect dialysis treatment, but no specific injuries have been reported. The risk is considered low.
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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-1351-2023 (January 24, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1351-2023 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.