FDA Device recall Z-1351-2023
Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System…
- FDA Device
- Class II
- ongoing
- Published 2023-04-19
On 2023-04-19 the FDA classified a Class II recall of Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System… by Outset Medical, citing an observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1351-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-01-24 |
| Published | 2023-04-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Outset Medical |
| Distribution | US |
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 facility.
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.
Identifiers
| code_info | Model Numbers: PN-0006000 PN-0007001 UDI-DI Code: 00850001011204 Serial Numbers for PN-00060000 600102M 600185M 600226…Model Numbers: PN-0006000 PN-0007001 UDI-DI Code: 00850001011204 Serial Numbers for PN-00060000 600102M 600185M 600226M 600229M 600241M 600251M 600307M 600383M 600430M 600554M 600668M 600684M 600741M 600742M 600747M 600757M 600774M 600815M 600816M 600817M 600826M 600828M 600829M 600856M 600858M 600867M 600869M 600875M 600899M 600904M 600925M 600932M 600947M 600954M 600964M 600974M 600981M 600983M 600987M 600988M 601051M 601052M 601053M 601055M 601061M 601069M 601071M 601073M 601074M 601078M 601079M 601083M 601087M 601091M 601092M 601093M 601094M 601097M 601101M 601103M 601104M 601106M 601111M 601112M 601113M 601118M 601119M 601120M 601124M 601125M 601126M 601127M 601128M 601129M 601130M 601131M 601132M 601135M 601136M 601137M 601138M 601139M 601140M 601141M 601142M 601143M 601144M 601145M 601146M 601147M 601148M 601149M 601150M 601151M 601152M 601155M 601156M 601157M 601158M 601159M 601160M 601161M 601162M 601164M 601166M 601167M 601169M 601171M 601172M 601173M 601174M 601175M 601176M |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1351-2023%22
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