medical Class II Updated 2018-05-09

IntroMedic Co., Ltd. recalls Miriam Capsule Endoscope System. Model MR1100 Product Usa

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: None
View official government recall

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