FDA Medical Device Recalls (openFDA)
IntroMedic Co., Ltd.: 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.
- Recall number
- Z-1615-2018
- Recalling firm
- IntroMedic Co., Ltd.
- 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.
- Status
- Terminated
- Initiated
- 2017-02-15
- Posted
- not on file
- Terminated
- 2018-08-08
- Reason
- 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.
- Root 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
- 82
- Distribution
- Us Nationwide Distribution in the states of: NY, MD, TX, IL, IN, KY, FL, OH, TN, CA, GA, KS, MO & NC
- Lot, serial or model codes
- None
- 510(k) numbers
- ["K123428"]
- PMA numbers
- not on file
- Product code
- NEZ
- Firm FEI
- 3013489112
- Firm city
- Dongan
- Firm state
- not on file
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28