Z-1615-2018 Class II Terminated
FDA device recall Z-1615-2018 was initiated by IntroMedic Co., Ltd. on February 15, 2017 and is designated Class II. 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. The recall status is terminated (terminated August 8, 2018). Affected quantity: 82.
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- February 15, 2017
- Termination Date
- August 8, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 82
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.
Distribution Pattern
Us Nationwide Distribution in the states of: NY, MD, TX, IL, IN, KY, FL, OH, TN, CA, GA, KS, MO & NC
Code Information
None