Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000 Recalled by Outset Medical, Inc. Due to Due to a component in the hemodialysis console...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Outset Medical, Inc. directly.
Affected Products
Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
Quantity: 1,123 systems (PN-0003000) and 1,487 (PN-0006000)
Why Was This Recalled?
Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Outset Medical, Inc.
Outset Medical, Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report