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.
Z-1615-2018
Product summary
- Event
- Event 79830
- Status
- Terminated
- Classification
- Class II
- Quantity
- 82
- Official record key
device-enforcement:Z-1615-2018
Official wording
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.
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
Derived failure modes
-
Unknown
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.