The Recall Desk
HighFDA (Devices)·Z-0813-2022·Announced 2022-03-30

Outset Tablo Hemodialysis Console Recalled for Heat Damage Risk

Outset Medical is recalling Tablo hemodialysis consoles (models PN-0003000 and PN-0006000) nationwide due to a component that may cause heat-related damage to the device.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall without reported illnesses or injuries. The hazard involves potential heat-related component damage to a critical medical device (hemodialysis console), representing a risk-of-harm product where injury has not yet been reported, fitting the Score 3 criterion.

Plain-English summary

Outset Medical, Inc. is recalling Outset Tablo hemodialysis consoles, Model Numbers PN-0003000 and PN-0006000, due to a component that may cause heat-related damage to the device.

The recall involves 1,123 systems of Model PN-0003000 and 1,487 systems of Model PN-0006000. These devices were distributed nationwide throughout the United States.

Heat-related damage to the device component may affect proper device operation. Patients and healthcare facilities using affected consoles should contact Outset Medical for information regarding the recall remedy.

The recalled product

Product
Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
Manufacturer
Outset Medical, Inc.
Category
Medical Device — Hemodialysis
Hazard
  • heat-damage
  • device-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model Numbers: PN-0003000 UDI Codes: (01)00850001011112(11)200218

Distribution

Distributed nationwide across the United States.

Related recalls

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