Recall Z-1615-2018— IntroMedic Co., Ltd.

Name: FDA recall Z-1615-2018
Creator: U.S. Food and Drug Administration
Published: 2017-02-15

Class II · Terminated

Class II FDA medical device recall by IntroMedic Co., Ltd., initiated 2017-02-15, terminated 2018-08-08. It names one FDA 510(k) clearance: K123428. 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: 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..

Recalling firm: IntroMedic Co., Ltd.
Classification: Class II
Status: Terminated
Initiated: 2017-02-15
Terminated: 2018-08-08
Firm location: Anyang, N/A, Korea (the Republic of)

510(k) clearances named in this recall

1 on FDA's record

K123428 — MIROCAM CAPSULE ENDOSCOPE SYSTEMIntromedic Co., Ltd.·cleared 2013-05-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.