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EPIONE RoboKit Plus
QUANTUM SURGICAL · Model 09-0046 · UDI-DI 03760305400253
LRO
Prescription
10
510(k) clearances
22,538
Adverse events (2 deaths)
1,084
Recalls
161
Facilities
Description
The EPIONE® RoboKit™ Plus is used during the CT guided procedures performed with EPIONE®. Sterile drapes are used to cover: the robotic arm, the touchscreen of the display cart, the tray of the display cart supporting the mouse and the keyboard. Reflective spheres to be placed on the tracked EPIONE instruments tracked. The EPIONE® RoboKit™ Plus includes the accessories individually packaged in their primary packaging considered as sterile, but the EPIONE® RoboKit™ Plus is not sterile.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-24 | Cardinal Health 200, LLC | Kits contain infusion sets which were recalled for performance issues. |
| 2026-09-08 | AVID Medical, Inc. | Potential for open seals on header bags, compromising sterility. |
| 2026-09-08 | AVID Medical, Inc. | A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications. |
| 2026-09-08 | AVID Medical, Inc. | A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications. |
| 2026-09-02 | Medline Industries, LP | Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking durin |
| 2026-08-31 | Medline Industries, LP | Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result |
| 2026-08-31 | Medline Industries, LP | Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result |
| 2026-08-18 | Cardinal Health 200, LLC | The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the fl |
| 2026-08-11 | Medline Industries, LP | The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu |
| 2026-08-10 | AVID Medical, Inc. | Product may be potentially contaminated with a lubricant used during the manufacturing process. |
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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.