| 2024-08-01 |
Class II
|
Ongoing |
Z-0019-2025 |
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indi… |
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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 coul… |
| 2024-04-30 |
Class II
|
Ongoing |
Z-2150-2024 |
TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747… |
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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 d… |
| 2024-03-06 |
Class I
|
Ongoing |
Z-1485-2024 |
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 |
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Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxi… |
| 2023-01-24 |
Class II
|
Ongoing |
Z-1351-2023 |
Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis … |
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An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process. |
| 2022-01-20 |
Class II
|
Ongoing |
Z-0813-2022 |
Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000 |
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Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device. |