Class 2 Device Recall MiroCam Capsule Endoscope Syste

• Date Initiated by Firm: February 15, 2017
• Create Date: May 03, 2018
• Recall Status: Terminated on August 08, 2018
• Recall Number: Z-1615-2018
• Recall Event ID: 79830
• 510(K)Number: K123428
• Product Classification: System, imaging, gastrointestinal, wireless, capsule - Product Code NEZ
• Product: Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.
• Code Information: None
• FEI Number: 3013489112
• Recalling Firm/ Manufacturer: IntroMedic Co., Ltd.; F-Rtek 6 Floor; 11-25 Simindaero327beon-Gil; Dongan; Anyang Korea (the Republic of)
• Manufacturer Reason for Recall: When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was displayed as orange color due to momentary drop of battery voltage.
• FDA Determined Cause: Device Design
• Action: Intromedic representatives visited hospitals with the affected products after the first awareness of the problem in order to explain the corresponding issue to our distributor in USA and gave them training on how to check the software before and after the software update. Firm revisited the hospitals in which the software was not conducted by our distributor and carried out the software update since Nov 13th, 2017. The software update was not made immediately as we believe that the reoccurrence possibility of this issue is very low since have not received any other report of the issue from USA and other countries, and the receiver works fine after it is turned off and on again. Some of the hospitals visited refused to conduct software update while being aware of the issue as they were not encountered with the issue. The remaining hospitals in which software update is not conducted will be visited and software update will be conducted by firm's distributor by April.
• Quantity in Commerce: 82
• Distribution: Us Nationwide Distribution in the states of: NY, MD, TX, IL, IN, KY, FL, OH, TN, CA, GA, KS, MO & NC
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NEZ