Outset Tablo Model Numbers — Class II medical device recall Z-1351-2023
Ongoing recall by Outset Medical, Inc., reported 2023-04-19, distributed nationwide. An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a
| Recall number | Z-1351-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Outset Medical, Inc., San Jose, CA, United States |
| Recall initiated | 2023-01-24 |
| Classified | 2023-04-07 |
| Reported by FDA | 2023-04-19 |
| Distributed | Nationwide (US) |
| Quantity | 374 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00850001011204 |
| Serial numbers | 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 and 351 more |
| Model numbers | PN-0006000, PN-0007001 |
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 for recall
An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1351-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.