IntroMedic Co., Ltd. recalls Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualiza…

Recall date

February 15, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1615-2018

FDA classification

Class II

Brand / firm

IntroMedic Co., Ltd.

Sold / distributed

Us Nationwide Distribution in the states of: NY, MD, TX, IL, IN, KY, FL, OH, TN, CA, GA, KS, MO & NC

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.