FDA Device recall Z-0813-2022
Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
- FDA Device
- Class II
- ongoing
- Published 2022-03-30
On 2022-03-30 the FDA classified a Class II recall of Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000 by Outset Medical, citing due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0813-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-20 |
| Published | 2022-03-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Outset Medical |
| Distribution | US |
Product
Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
Reason
Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.
Identifiers
| code_info | Model Numbers: PN-0003000 UDI Codes: (01)00850001011112(11)200218; Serial Numbers: 400270 400275 400280 400818 400084 4…Model Numbers: PN-0003000 UDI Codes: (01)00850001011112(11)200218; Serial Numbers: 400270 400275 400280 400818 400084 400088 400097 400098 400101 400102 400103 400476 400479 400505 400113 400122 400155 400159 400352 400353 400156 400157 400163 400164 400492 400498 400250 400265 400269 400273 400283 400816 400819 400820 400828 400234 400235 400236 400672 400685 400100 400104 400124 400481 400486 400231 400243 400244 400245 400248 400668 400686 400165 400168 400181 400359 400381 400258 400267 400271 400274 400278 400826 400225 400228 400229 400230 400281 400282 400483 400494 400495 400501 400504 400506 400507 400509 400510 400512 400262 400264 400864 400875 400876 400823 400825 400831 400835 401041 401046 401056 401059 401061 401062 401065 401066 401067 401069 401070 401071 400878 400879 400887 400896 400901 401199 401200 401201 401203 401204 400829 400830 400905 400907 400649 400651 400659 400666 400116 400121 400650 400653 400277 400708 400770 400115 400312 400330 400087 400095 400114 |
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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-0813-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.