Outset Medical, Inc.: 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 a

Hazard

An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.

Details from the source

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. Distribution: U.S. Nationwide distribution including in the states of AK, AL, AR, CA, CO, FL, GA, HI, IA, ID, IL, IN, MI, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, and WI. O.U.S.: Not provided. Quantity: 374 systems Lot/code info: 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 601177M 601178M 601179M 601180M 601182M 601185M 601186M 601187M 601190M 601192M 601193M 601194M 601195M 601196M 601197M 601198M 601199M 601200M 601201M 601202M 601203M 601204M 601206M 601207M 601209M 601210M 601211M 601212M 601213M 601214M 601215M 601216M 601217M 601218M 601219M 601221M 601222M 601223M 601224M 601226M 601227M 601230M 601231M 601232M 601233M 601234M 601235M 601236M 601237M 601238M 601241M 601243M 601245M 601246M 601247M 601250M 601251M 601252M 601254M 601255M 601256M 601257M 6012

UPC codes

00850001011204

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.