Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported May 6, 2026
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.
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 setti…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Hologic, Inc recalled Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco M… - a moderate-severity action.
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco M… was recalled by Hologic, Inc in May 6, 2026. Reason: It was identified that certain devices were being operated outside the validated and FDA-cleared display conf…. Check the official notice for the remedy. Verify recall #Z-1949-2026 with the FDA Devices before acting.
The recall
Hologic, Inc issued this moderate-severity FDA Devices recall-It was identified that certain devices were being operated outside the validated and FDA-cleared display conf….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- May 6, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1949-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1949-2026) was formally reported on May 6, 2026, with the manufacturer initiating the action on March 23, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Hologic, Inc is listed as the recalling firm, operating out of Marlborough, MA. Federal records list the affected scope as 1200 units.
The documented reason for this recall is: 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 Ba… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1200 units
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1949-2026 |
| Date reported | May 6, 2026 |
| Date initiated | March 23, 2026 |
| Recalling firm | Hologic, Inc |
| Firm location | Marlborough, MA |
| Affected scope | 1200 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1949-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hologic, Inc. Units affected: 1200 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2026. Severity: Moderate. Recall number: Z-1949-2026.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1949-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 6, 2026. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.