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.
An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.
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.
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.
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.
Check for model numbers PN-0006000 or PN-0007001 on the device. Affected units have specific serial numbers listed in the recall notice.
Look for model numbers PN-0006000 or PN-0007001 on the Tablo device.
The recall is due to an observed trend of high conductivity dialysate alarms caused by a software change introduced during manufacturing.
Check the device model and serial numbers against the list provided in the recall notice. If affected, contact Outset Medical for further instructions.
The recall indicates a potential for incorrect dialysis treatment, but no specific injuries have been reported. The risk is considered low.
We’ve drafted a message you can send Outset to request your refund or repair — edit it as you like.
Subject: Recall Z-1351-2023 — Outset Outset Hello, I own a Outset that is covered by recall Z-1351-2023 from Outset. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
