- Recalling firm
- Hologic, Inc
- 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.
- Affected products (lot / model / serial)
- Model Number: CMP-01669; UDI-DI: 15420045514201; Serial Number: All;
- Units affected
- 1200 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.
- Firm location
- Marlborough, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1949-2026
- Recall initiated
- March 23, 2026
- FDA classification date
- April 24, 2026
- FDA report date
- May 6, 2026
- FDA event ID
- 98487
- Last updated on HTM Vibe
- July 24, 2026