Reported May 9, 2018 · Terminated
Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for…
IntroMedic Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: IntroMedic Co., Ltd. · F-Rtek 6 Floor · Anyang, N/A · N/A
Is this the product you have?
- Miriam Capsule Endoscope System
- Model MR1100 Product UsageMiroCam 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
- Lot codes and dates
- None
- Amount recalled
- 82
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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