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.
Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.
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.
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.
Hemodialysis patients and healthcare providers who own or use the affected console models. The risk is low and not expected to cause serious injury.
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.
Look for model numbers PN-0003000 or PN-0006000 on the console.
Check the full list of affected serial numbers and UDI codes provided in the recall notice.
A component in the console may overheat, potentially causing heat-related damage. This is not expected to cause serious injury but may require attention.
Check for model numbers PN-0003000 or PN-0006000. Affected units have specific serial numbers and UDI codes listed in the recall notice.
The recall does not specify a fix; affected units should be checked against the list of serial numbers and UDI codes provided in the notice.
We’ve drafted a message you can send Outset Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0813-2022 — Outset Medical Outset Medical Hello, I own a Outset Medical that is covered by recall Z-0813-2022 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.
