Z-0595-2018 Class II Terminated
FDA device recall Z-0595-2018 was initiated by Hologic, Inc on Jan 20, 2018 and is designated Class II. 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. The recall status is terminated (terminated Jul 28, 2022). Affected quantity: 103 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 21, 2018
- Initiation Date
- Jan 20, 2018
- Termination Date
- Jul 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0595-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026