Recall Z-1351-2023 ยท FIP Subsystem, Water Purification
Outset Medical, Inc.
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 facility.
| Date | Apr 7, 2023 (initiated Jan 24, 2023) |
| Status | Open, Classified |
| Reason | An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process. |
| Root cause | Process control |
| Action | On 01/24/2023, the firm communicated an "MEDICAL DEVICE FIELD ACTION" Letter via FedEx Standard Overnight to customers informing them that Outset Medical has identified that Tablo Hemodialysis Systems manufactured between May 2021 and February 2022 require recalibration of the conductivity sensor, due to the dialysate conductivity sensor giving potentially false trigger alarms such as Alarm_Dialysate_Conductivity_High or Dialysate Conductivity Error. In addition, in devices where recalibration is needed and isolated only to treatments where the prescribed sodium is less than or equal to 133mE |
| Quantity | 374 systems |
| Distribution | U.S. Nationwide distribution including in the states of AK, AL, AR, CA, CO, FL, GA, HI, IA, ID, IL, IN, MI, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, and WI. O.U.S.: Not provided. |
| FDA record | Open on fda.gov |