Every recall we track for Outset Medical, Inc. — 5 in all — plus the complaints and injury reports the public filed about them.
Outset Medical recalls Tablo Console models PN-0003000 and PN-0006000 due to blood leak sensor potentially delaying alarm for hemodialysis patients, risking hypotension and other symptoms. Affected units have specific serial numbers listed in the recall.
Outset Medical recalls TabloCart with Prefiltration Drawer (PN-0006813) with specific power cords due to potential electrical hazards from damaged connectors that could cause heat, sparks, or fire. Affected units may need replacement.
Outset Medical recalls Tablo Hemodialysis Systems with specific part numbers due to potential PCBAs in tubing that could cause skin conditions, liver damage, and cancer risks. Affected units have serial numbers listed in the recall.
Outset Medical recalls Tablo hemodialysis systems (model PN-0006000, PN-0007001) due to high conductivity dialysate alarms from software changes. Affected units have specific serial numbers.
Outset Medical recalls two models of hemodialysis consoles (PN-0003000 and PN-0006000) due to a component that may cause heat-related damage. Affected units have specific serial numbers and UDI codes listed in the recall notice.
