Recall Z-1615-2018 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
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.
| Date | Feb 15, 2017 |
| Status | Terminated |
| 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 |
| Quantity | 82 |
| Distribution | Us Nationwide Distribution in the states of: NY, MD, TX, IL, IN, KY, FL, OH, TN, CA, GA, KS, MO & NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123428 | MIROCAM CAPSULE ENDOSCOPE SYSTEM Intromedic Co., Ltd., May 20, 2013 |