Recall Z-0280-2023— Visionsense, Ltd.

Name: FDA recall Z-0280-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-17

Class II · Ongoing

Class II FDA medical device recall by Visionsense, Ltd., initiated 2022-10-17. It names one FDA 510(k) clearance: K150018. Product: VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012. 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..

Recalling firm: Visionsense, Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2022-10-17
Firm location: Petakh Tikva, N/A, Israel

510(k) clearances named in this recall

1 on FDA's record

K150018 — VS3-IR-MMS SystemVisionsense, Ltd.·cleared 2015-06-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.