Reported Apr 19, 2023 · Ongoing
Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system…
Outset Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Outset Medical, Inc. · 3052 Orchard Dr · San Jose, CA · 95134-2011
Is this the product you have?
- 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
- Lot codes and dates
- Model NumbersPN-0006000
- PN-0007001 UDI-DI Code00850001011204 Serial Numbers for
353 of 353 codes
PN-00060000600102M600185M600226M600229M600241M600251M600307M600383M600430M600554M600668M600684M600741M600742M600747M600757M600774M600815M600816M600817M600826M600828M600829M600856M600858M600867M600869M600875M600899M600904M600925M600932M600947M600954M600964M600974M600981M600983M600987M600988M601051M601052M601053M601055M601061M601069M601071M601073M601074M601078M601079M601083M601087M601091M601092M601093M601094M601097M601101M
- Serial Numbers for PN-0007001
601098M601099M601107M601108M601110M601115M601116M601117M601184M601188M601189M601301M601303M601306M601309M601351M601572M601576M601577M601584M601585M601591M
- Amount recalled
- 374 systems
Where it was sold
Why it was recalled
An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.
This product could cause temporary or reversible health problems — stop using it.
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