FDA
Outset Tablo Console
Model Number: PN-0003000
Model Number: PN-0006000
Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.
On 01/20/2022, the firm send a "MEDICAL DEVICE FIELD ACTION" Letter to customers informing them that Outset Medical is proactively replacing a component on the Talbo Hemodialysis consoles due to the possibility of heat-related damage that may occur to the Tablo device. Outset Medical has identified that Tablo Hemodialysis Systems manufactured between July 6, 2018 and November 24, 2021 require the component replacement. Outset is indicating that the replacement will be completed within the next twelve months during the next routine maintenance or at the next service call. Outset Field Service Engineers will coordinate completion of the replacement.
Customers are instructed to complete the acknowledgement form and promptly return to Outset Medical
For questions, contact Outset Customer Experience Team at 844-698-2256.