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Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument...

FDA Device Recall #Z-0595-2018 — Class II — January 20, 2018

Recall Summary

Recall Number Z-0595-2018
Classification Class II — Moderate risk
Date Initiated January 20, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Hologic, Inc
Location San Diego, CA
Product Type Devices
Quantity 103 units

Product Description

Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of nucleic acid testing on a single, integrated platform. The Panther can be test samples with random access or batch managed; can perform multiple assays on the same patient sample with up to 4 different assays simultaneously.

Reason for Recall

The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator.

Distribution Pattern

Worldwide distribution

Lot / Code Information

Serial Numbers: 2090002307, 2090002308, 2090002309, 2090002310, 2090002311, 2090002312, 2090002339, 2090002340, 2090002341, 2090002342, 2090002343, 2090002344, 2090002345, 2090002346, 2090002347, 2090002348, 2090002349, 2090002350, 2090002351, 2090002352, 2090002353, 2090002359, 2090002360, 2090002361, 2090002362, 2090002363, 2090002366, 2090002367, 2090002368, 2090002369, 2090002370, 2090002371, 2090002372, 2090002373, 2090002374, 2090002381, 2090002382, 2090002383, 2090002384, 2090002385, 2090002387, 2090002388, 2090002389, 2090002390, 2090002391, 2090002393, 2090002404, 2090002405, 2090002406, 2090002407, 2090002409, 2090002411, 2090002413, 2090002414, 2090002415, 2090002420, 2090002421, 2090002422, 2090002428, 2090002429, 2090002430, 2090002432, 2090002433, 2090002434, 2090002435, 2090002436, 2090002437, 2090002438, 2090002446, 2090002447, 2090002448, 2090002449, 2090002450, 2090002451, 2090002452, 2090002458, 2090002462, 2090002465, 2090002466, 2090002467, 2090002468, 2090002469, 2090002470, 2090002471, 2090002472, 2090002473, 2090002476, 2090002481, 2090002483, 2090002484, 2090002485, 2090002338, 2090002394, 2090002417, 2090002431, 2090002463, 2090002464, 2090002492, 2090002491, 2090002490, 2090002489, 2090002488

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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