Outset Medical recalls Tablo Console models PN-0003000 and PN-0006000 due to blood leak sensor potentially delaying alarm for hemodialysis patients, risking hypotension and other symptoms. Affected units have specific serial numbers listed in the recall.
Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if blood loss, less-than 300ml, occurs, the patient may experience hypotension, fatigue, cramps, dizziness, headaches, nausea, and shortness of breath.
Outset Medical is recalling Tablo Console models PN-0003000 and PN-0006000 as part of their hemodialysis system. The blood leak sensor may not trigger the alarm at the lowest blood leak rate of 0.35 mL/min, which could delay detection of blood loss under 300ml and cause symptoms like dizziness, fatigue, and shortness of breath in patients.
The blood leak sensor in the Tablo Console may show decreased sensitivity at the lowest blood leak rate of 0.35 mL/min. If blood loss occurs under 300ml, the alarm may not trigger in time, potentially causing symptoms like dizziness, fatigue, cramps, headaches, nausea, and shortness of breath.
Patients using the Tablo Hemodialysis System with the recalled Tablo Console models (PN-0003000 or PN-0006000) are most at risk. Healthcare facilities that use these consoles for hemodialysis treatments may also be affected.
Check if your Tablo Console has serial numbers listed in the recall: PN-0003000 or PN-0006000. The recall includes specific serial numbers starting with '60' followed by numbers and 'M' or '400' followed by numbers.
Look for the serial number on your Tablo Console to see if it matches the list of affected units provided in the recall.
If your console is affected, contact Outset Medical directly for further instructions.
The blood leak sensor may show decreased sensitivity at the lowest blood leak rate of 0.35 mL/min, potentially delaying the alarm for blood loss under 300ml.
Patients may experience hypotension, fatigue, cramps, dizziness, headaches, nausea, and shortness of breath if blood loss occurs under 300ml and the alarm is delayed.
Check the serial number on your console against the list of affected units provided in the recall, which includes specific serial numbers starting with '60' followed by numbers and 'M' or '400' followed by numbers.
We’ve drafted a message you can send Outset Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0019-2025 — Outset Medical Outset Medical Hello, I own a Outset Medical that is covered by recall Z-0019-2025 from Outset Medical. 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.
