Capso Vision Recalls CapsoCam Plus Capsule Endoscopy Systems Due to Labeling Errors

Plain-English summary

Capso Vision, Inc. is recalling 44 units of the CapsoCam Plus video capsule system. This medical device is intended for the visualization of the small bowel mucosa in adults to help detect abnormalities. The recall was initiated because the devices may have been mis-labeled with incorrect serial numbers.

The potential for incorrect serial number labels creates a risk that a patient's medical records may be associated with the wrong device data, which may result in a misdiagnosis. The affected units were distributed nationwide in the United States, including in the states of Florida, Georgia, New York, Pennsylvania, and Texas.

Healthcare providers and facilities that have received these devices should stop using them and contact Capso Vision, Inc. for instructions on how to return the units. Patients who have used these devices should contact their healthcare provider to discuss their medical records and ensure that the correct data was used for their diagnosis.

The recalled product

Product

CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of

Manufacturer

Capso Vision, Inc.

Category

Medical Device — Endoscopy

Hazard

• mis-labeling

Affected units

44

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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