Class II — IntroMedic Co., Ltd.
| Recalling firm | IntroMedic Co., Ltd. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| 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. |
| 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. |
| Quantity | 82 |
| Distribution | Us Nationwide Distribution in the states of: NY, MD, TX, IL, IN, KY, FL, OH, TN, CA, GA, KS, MO & NC |
| Initiated | 2017-02-15 |
| Classified | 2018-05-03 |
| Terminated | 2018-08-08 |
| Recall number | Z-1615-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — IntroMedic Co., Ltd. (Z-1615-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79830/
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