Outset Medical recalls
5 official recalls and safety alerts involving Outset Medical since 2022-03, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Outset Medical or the relevant agency.
- 2024-10-09
USOutset Medical, Inc. recalls Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in…
Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if…
FDA · DeviceOutset Medical, Inc.US: CA, NY, IL, MO, KY, AZ, PA, FL, GA, AK, NM, VA, NC, SC, OK, AL, MA, OH,…Official notice →- 2024-06-26
- US
Outset Medical, Inc. recalls TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15-…
A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create localized heat, sparks, smoke,…
FDA · DeviceOutset Medical, Inc.US Nationwide distribution in the states of FL, CA, NC, GA, MD, DE, AK, OK,…Official notice → - 2024-04-24
- US
Outset Medical, Inc. recalls Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that…
FDA · DeviceOutset Medical, Inc.US:FL, CA, NM, SC, AZ, TN, NC, TX, IL, MD, IN, DE, AL, MI, AK, KY, LA, ID, OK,…Official notice → - 2023-04-19
- US
Outset Medical, Inc. recalls Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis…
An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.
FDA · DeviceOutset Medical, Inc.U.S. Nationwide distribution including in the states of AK, AL, AR, CA, CO,…Official notice → - 2022-03-30
- US
Outset Medical, Inc. recalls 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.
FDA · DeviceOutset Medical, Inc.U.S. Nationwide distribution in the states of AL, AK, AZ, CA, CO, CT, DC, DE,…Official notice →