Hologic, Inc recalls
4 recalls on record · 1 rated Critical · FDA
Every recall we have on record for Hologic, Inc, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC,…
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco…
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducted to restore affected system to the validated configuration and reinforce proper use in accordance with the Operator's Manual.
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical…
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites…
Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device