Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
FDA Recall Z-0813-2022 · Posted None
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Recalling FirmOutset Medical, Inc.
Recall StatusOpen, Classified
Product CodeKDI
Date Initiated2022-01-20
Product Quantity1,123 systems (PN-0003000) and 1,487 (PN-0006000)
Reason for Recall
Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
U.S. Nationwide distribution in the states of AL, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NY, NM, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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