FDA Device recall Z-1615-2018
Miriam Capsule Endoscope System
- FDA Device
- Class II
- terminated
- Published 2018-05-09
On 2018-05-09 the FDA classified a Class II recall of Miriam Capsule Endoscope System by Intromedic, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1615-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-15 |
| Published | 2018-05-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Intromedic |
| Distribution | US |
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
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.
Identifiers
| code_info | None |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1615-2018%22
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