IntroMedic Recalls Miriam Capsule Endoscope System Due to Battery Indicator Error
IntroMedic Co., Ltd. is recalling 82 units of the Miriam Capsule Endoscope System because the battery indicator may incorrectly display orange when the battery is fully charged.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a misleading battery indicator that could lead to unexpected device shutdown during a procedure, but no injuries or illnesses are reported in the source text.
Plain-English summary
IntroMedic Co., Ltd. is recalling 82 units of the Miriam Capsule Endoscope System, Model MR1100. The recall is due to a defect in the MR1100 Receiver where the battery status LED may display an orange color, indicating a low charge, even when the battery is fully charged. This occurs due to a momentary drop in battery voltage when the device is switched on.
The affected devices were distributed nationwide in the United States, specifically in the states of New York, Maryland, Texas, Illinois, Indiana, Kentucky, Florida, Ohio, Tennessee, California, Georgia, Kansas, Missouri, and North Carolina. The product is intended for the visualization of the small bowel mucosa in adults.
Users should stop using the affected devices and contact IntroMedic Co., Ltd. for further instructions regarding the recall.
The recalled product
- 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.
- Manufacturer
- IntroMedic Co., Ltd.
- Category
- Medical Device — Endoscopy
- Affected units
- 82
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- None
Distribution
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