Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
Check against the official notice below — it lists the full affected range.
Outset Medical, Inc. is recalling Outset Tablo Console hemodialysis devices due to a component that may cause heat-related damage to the device. The recall affects 1,123 systems of Model Number PN-0003000 and 1,487 systems of Model Number PN-0006000 distributed nationwide across all U.S. states and Washington, D.C. Consumers can identify affected devices by their model number and serial number, which are listed in the recall notice.
The recall source does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.
Reason for recall: Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device. Distribution: U.S. Nationwide distribution in the states of AL, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NY, NM, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY. Quantity: 1,123 systems (PN-0003000) and 1,487 (PN-0006000) Lot/code info: 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 401129 401133 401174 401179 401232 401233 401234 401235 400889 400898 400059 400062 400063 400923 400937 400946 400950 400085 400096 400106 400107 400108 400130 400147 400154 400691 400694 400698 400529 400531 400890 400842 400851 400865 400880 400881 400917 401076 401155 401159 401162 401164 401166 401168 401169 401170 401175 401182 401188 401202 401206 401207 401212 401218 401228 400050 400071 400169 400180 400186 400192 400193 400622 400627 400628 400632 400633 400634 400635 400636 400641 400
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.