Hologic Panther — Class II medical device recall Z-0595-2018
Terminated recall by Hologic, Inc, reported 2018-02-21. The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potent
| Recall number | Z-0595-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, San Diego, CA, United States |
| Recall initiated | 2018-01-20 |
| Classified | 2018-02-12 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2022-07-28 |
| Quantity | 103 units |
| Reason classes | foreign material |
| Serial numbers | 2090002307, 2090002308, 2090002309, 2090002310, 2090002311, 2090002312, 2090002338, 2090002339, 2090002340, 2090002341, 2090002342, 2090002343, 2090002344, 2090002345, 2090002346, 2090002347, 2090002348, 2090002349, 2090002350, 2090002351, 2090002352, 2090002353, 2090002359, 2090002360, 2090002361 and 77 more |
| Model numbers | ASY-09600 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0595-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.