CLASS II ONGOING Device recall · Reported 6 May 2026 · FDA Enforcement Report

Genius" Review Station Display (Barco Monitor) recalled by Hologic

Hologic is recalling Genius" Review Station Display (Barco Monitor), distributed nationwide in the US. The recall was initiated on 23 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: CMP-01669; UDI-DI: 15420045514201; Serial Number: All;

Quantity recalled1200 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1949-2026
FDA event ID: 98487
Recalling firm: Hologic, Marlborough, MA
Classification: Class II
Status: Ongoing
Recall initiated: 23 Mar 2026
FDA classified: 24 Apr 2026
Reported: 6 May 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

23 Mar 2026	Recall initiated by company
24 Apr 2026	Classified by FDA	+32 days
6 May 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Model Number: CMP-01669; UDI-DI: 15420045514201; Serial Number: All;

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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