Z-1949-2026Class II

Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog...

Name: Z-1949-2026 Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog...
Creator: Hologic, Inc
Published: 2026-03-23
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2026-03-23 / Open, Classified / root cause: software

FDA source

Hologic, Inc began a recall of Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not... on 2026-03-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1949-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-23
Posted: 2026-04-24
Recalling firm: Hologic, Inc.
Product: Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035.
Product code: QYV Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: On March 23, 2026, Urgent Medical Device Recall letters were sent to customers. Actions to be taken: If you are receiving this notification, our records indicate that you have received a Genius" Review Station Monitor (CMP-01669). As this field correction applies to all monitors, please follow the instructions below and complete the Customer Response Form (CRF) using the link or QR code provided below. If you are a distributor or otherwise supply Genius" Review Station Monitors to downstream customers, you are responsible for promptly forwarding this notification to all affected sub-accounts and ensuring completion of the CRF for each end-user site. Do not change monitor settings " Continue to use the Genius" Review Station only with the original monitor settings configured by Hologic at installation. " Do not: " Disable Barco Application Appearance Manager (AAM) " Change Barco QAWeb calibration or compliance test settings " Adjust or otherwise modify the monitor configuration parameters outside of the original configuration by Hologic at installation. " Only Hologic, or its authorized provider may modify Genius" Review Station monitor configuration settings. If monitor settings have been altered " If you are aware that monitor display or calibration settings have been changed from the original configuration, do not use the Genius" Review Station monitor for clinical review until the monitor has been returned to the original configuration by Hologic or its authorized service provider. " Complete the Customer Response Form (CRF) so Hologic and its field service partner, IQVIA MedTech, can coordinate restoration of the approved configuration. Please promptly fill out the Customer Response Form (CRF) to acknowledge you have received this notification. Distributors should ensure that all downstream customers complete the CRF or provide the required information on their behalf.
Quantity in commerce: 1200 units
Distribution: Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.
Product codes and lots: Model Number: CMP-01669; UDI-DI: 15420045514201; Serial Number: All;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1949-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1949-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-24

Product code QYV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)