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Nova 5
C4 IMAGING, LLC · Model F-01-03-0111 · UDI-DI 00863593000259
NEU
Prescription
1
510(k) clearances
1,870
Adverse events (1 deaths)
14
Recalls
102
Facilities
Description
The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobalt chloride and up to 2.0% N-Acetyl cysteine, in a ratio of 1:2. Zirconium oxide is sealed within the device. The length of the polymer capsule is between 5.5 mm and 10.0 mm, and the diameter is 1.0 mm. It is loaded in an implant needle and sterilized with Ethylene Oxide.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-24 | Devicor Medical Products Inc | Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers. |
| 2026-01-21 | Stryker Corporation | Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedure |
| 2025-10-01 | ENDOMAGNETICS LTD | Potential for contamination with cotton fibers. |
| 2025-10-01 | ENDOMAGNETICS LTD | Potential for contamination with cotton fibers. |
| 2024-11-18 | Elucent Medical Inc | There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when |
| 2024-10-10 | Hologic, Inc | Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort. |
| 2024-03-13 | Hologic, Inc | Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complication |
| 2022-12-16 | Carbon Medical Technologies, Inc. | The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, a 1x5mm Tribell shap |
| 2022-08-09 | Hologic, Inc | Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expirat |
| 2022-03-30 | Devicor Medical Products Inc | Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectl |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.