Miriam Capsule Endoscope System — Class II medical device recall Z-1615-2018
Terminated recall by IntroMedic Co., Ltd., reported 2018-05-09, distributed nationwide. When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was displayed as o
| Recall number | Z-1615-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | IntroMedic Co., Ltd., Anyang, N/A, Korea (the Republic of) |
| Recall initiated | 2017-02-15 |
| Classified | 2018-05-03 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2018-08-08 |
| Distributed | Nationwide (US) |
| Quantity | 82 |
| Model numbers | MR1100 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1615-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.