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Use caution Medical device recall · FDA · Published January 20, 2018

Hologic Panther Fusion: Glass panel may fall and hit operator

Hologic recalls Panther Fusion devices with serial numbers 2090002307-2492 due to risk of glass panel falling and hitting operators during use.

🇺🇸 FDA recall #Z-0595-2018Medical deviceHologic ›
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Recalling firmHologic, Inc10210 Genetic Center Dr · San Diego, CA 92121-4362
✎ GovInfoNow plain-language explainer

What happened, in plain English

Hologic is recalling specific models of their Panther Fusion devices because the glass panel can detach from the touch screen and fall, potentially hitting the operator. This poses a risk of injury during normal use. Read more at govinfonow.com/recall/72118-hologic-panther-fusion-glass-panel-may-fall-and-hit-operator.

Source Summary by GovInfoNow · govinfonow.com/recall/72118-hologic-panther-fusion-glass-panel-may-fall-and-hit-operator · Updated August 31, 2026 · FDA enforcement record: FDA #Z-0595-2018

Cite this page

“Hologic Panther Fusion: Glass panel may fall and hit operator.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72118-hologic-panther-fusion-glass-panel-may-fall-and-hit-operator. Based on FDA recall #Z-0595-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0595-2018%22&limit=1).

Why it’s dangerous

The glass panel that separates from the 19-inch touch screen monitor can detach and fall, potentially striking an operator. This hazard occurs during normal operation when the device is in use, as the panel is not securely attached.

Who’s affected

Users of the recalled Panther Fusion devices, particularly healthcare professionals who operate the equipment daily, are most at risk due to the potential for the glass panel to detach and fall during use.

How to tell if you have this one

Check for serial numbers starting with 2090002307 through 2090002492 on the device. The Panther Fusion is a fully automated medical device used for nucleic acid testing.

  • Brand
    Hologic
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Serial Number

    Look for the serial number on the device, which should be between 2090002307 and 2090002492.

  2. Stop Using Device

    If your device has a serial number in the affected range, stop using it immediately to prevent potential injury.

How this recall unfolded

Recall timeline

FDA terminated this recall 4.5 years after the firm started it.

1. Firm started the recall: Jan 20, 201812. FDA classified it Class II: Feb 12, 201823. Published in FDA’s Enforcement Report: Feb 21, 201834. FDA terminated the recall: Jul 28, 2022420182022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-0595-2018 (January 20, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0595-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA