Z-1615-2018Class II

Miriam Capsule Endoscope System. Model MR1100

Name: Z-1615-2018 Miriam Capsule Endoscope System. Model MR1100
Creator: IntroMedic Co., Ltd.
Published: 2017-02-15
License: https://open.fda.gov/license/

IntroMedic Co., Ltd. / initiated 2017-02-15 / Terminated / root cause: design

FDA source

IntroMedic Co., Ltd. began a recall of Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may... on 2017-02-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1615-2018
Classification: Class II
Status: Terminated
Initiated: 2017-02-15
Posted: 2018-05-03
Terminated: 2018-08-08
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.
Product code: NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
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.
Root cause tag: design
FDA 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 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
Product codes and lots: None

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1615-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1615-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-03

Product code NEZ

K123428Class IIMirocam Capsule Endoscope SystemIntromedic Co., Ltd. / cleared 2013-05-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)