FDA DeviceClass IINotable

FDA Recall: Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOn

Date: 2026-04-29
Brand: Foundation Medicine, Inc.
Category: Medical Device
FDA Class: Class II

Description

Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.

Hazard

Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.

Remedy

10 units

View original recall →
Share:

Related Recalls

2026-06-17 · FDA_DEVICE
FDA Recall: Allia Moveo angiographic X-ray system
GE Medical Systems, LLC
2026-06-17 · FDA_DEVICE
FDA Recall: Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
INSPIREMD Inc
2026-06-17 · FDA_DEVICE
FDA Recall: Plum Solo Precision IV Pump, 40001-0401
ICU Medical, Inc.
2026-06-17 · FDA_DEVICE
FDA Recall: Allia IGS 3 Pulse angiographic X-ray system
GE Medical Systems, LLC