Reported Mar 30, 2022 · Ongoing
Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
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 Console Model NumberPN-0003000
- Model NumberPN-0006000
- Lot codes and dates
- Model NumbersPN-0003000
- UDI Codes(01)00850001011112(11)200218
- Serial Numbers
1,123 of 1,123 codes
400270400275400280400818400084400088400097400098400101400102400103400476400479400505400113400122400155400159400352400353400156400157400163400164400492400498400250400265400269400273400283400816400819400820400828400234400235400236400672400685400100400104400124400481400486400231400243400244400245400248400668400686400165400168400181400359400381400258400267400271
- Model NumbersPN-0006000
- UDI Codes(01)00850001011204(11)201203
- Serial Numbers
1,487 of 1,487 codes
601129M601146M601261M601270M601298M600552M600785M600174M601138M601139M601149M601209M601210M601214M601218M601228M600260M600261M600217M600234M600238M600935M600946M600948M600151M600153M600131M600133M600702M600703M600758M400715400797400799400802400807400811600399M401251600727M600372600156M600161M600162M600165M600169M600170M600171M600172M600437M600460M600950M601301M601303M601306M601308M601309M600143600354600355
- Amount recalled
- 1,123 systems (PN-0003000) and 1,487 (PN-0006000)
Where it was sold
Why it was recalled
Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.
This product could cause temporary or reversible health problems — stop using it.
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