Recall Z-0282-2023 ยท OWN Confocal Optical Imaging
Visionsense, Ltd.
VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001
| Date | Nov 23, 2022 (initiated Oct 17, 2022) |
| Status | Open, Classified |
| Reason | Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface. |
| Root cause | Under Investigation by firm |
| Action | Medtronic issued Urgent Medical Device Correction Letter on 17-OCTOBER-2022 to US consignees via UPS 2-day delivery. For outside U.S. countries, notifications are handled via a regionally approved method. Letter states reason for recall, health risk and action to take: 1.Prior to use, visually check the Beam-Combiner and MMS optical fiber cable for signs of being pinched, kinkedor damaged. Avoid folding the cables and handle with care to prevent damage. 2.After the white balance has been performed as per IFU guidance, test the EleVision IR system at the beginningof the surgical procedure as |
| Quantity | 204 units: 93 units OUS ; 111 units US |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150018 | VS3-IR-MMS System Visionsense, Ltd., Jun 17, 2015 |