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Terminated

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.

FDA Recall Z-1615-2018 · Posted None

Recalling FirmIntroMedic Co., Ltd.
Recall StatusTerminated
Product CodeNEZ
Date Initiated2017-02-15
Date Terminated2018-08-08
Product Quantity82

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Us Nationwide Distribution in the states of: NY, MD, TX, IL, IN, KY, FL, OH, TN, CA, GA, KS, MO & NC

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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