Hologic recalls Genius Review Station Display (model CMP-016:01669) due to user modifications causing safety risks. Affected users should stop using modified devices until corrected.
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 is recalling its Genius Review Station Display (model CMP-01669) because users have modified the device settings, which can compromise safety. This recall is important because improper settings may lead to unsafe operation of the medical device.
The device can become unsafe if users disable the Barco Application Appearance Manager (AAM) or alter calibration settings. This may cause the display to malfunction during medical procedures, potentially leading to incorrect imaging results.
Healthcare professionals using the Genius Review Station Display for medical imaging are most at risk if they have made unauthorized software changes. Patients using the device may also be affected if the device malfunctions.
Check for the model number CMP-01669 on the device. The recall affects all units sold with this model number, regardless of software version.
Verify if the Barco Application Appearance Manager (AAM) is enabled and calibration settings are correct.
Reach out to Hologic for guidance on restoring the device to the validated configuration.
The recall is due to user modifications that can compromise safety by disabling the Barco Application Appearance Manager (AAM) or altering calibration settings.
Check for the model number CMP-01669 on the device. All units with this model number are affected.
Restore the device to the validated configuration as described in the Operator's Manual or contact Hologic for assistance.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-1949-2026 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-1949-2026 from Hologic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
