IntroMedic Co., Ltd.: Medical Device Recall in 2018 - (Recall #: Z-1615-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 15, 2017

Date Posted: May 9, 2018

Recall Number: Z-1615-2018

Event ID: 79830

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.

Status: Terminated

Product Quantity: 82

Code Information:

None

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated