FDA recall Z-1615-2018

IntroMedic Co., Ltd. · Class II · device

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 for recall

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2017-02-15
Report date
2018-05-09
Termination date
2018-08-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Anyang, N/A, Korea (the Republic of)

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1615-2018