Outset Tablo Hemodialysis System Recall Due to Software Manufacturing Defect
Outset Medical is recalling 374 Tablo hemodialysis systems due to a software malfunction introduced during manufacturing. The defect causes frequent high conductivity dialysate alarms in devices distributed nationwide.
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: This is an FDA Class II device recall with no reported injuries or illnesses. However, it involves a life-critical hemodialysis system with a software malfunction affecting system alarms, fitting the criterion of a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Outset Medical is recalling 374 Tablo hemodialysis systems (Model Numbers PN-0006000 and PN-0007001). The systems are being recalled due to a software defect introduced during manufacturing that causes an observed trend of frequent high conductivity dialysate alarms.
The Tablo is a self-contained hemodialysis system intended for acute, home, and chronic dialysis therapy, with or without ultrafiltration, in acute or chronic care facilities.
The 374 affected systems were distributed nationwide throughout the United States, including in Alaska, Alabama, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, and Wisconsin. Specific serial numbers identifying the recalled units are available from Outset Medical and the FDA.
The recalled product
- Product
- Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facil
- Manufacturer
- Outset Medical, Inc.
- Hazard
- software-malfunction
- false-alarm
Distribution
Distributed nationwide across the United States.
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