Capso Vision

3 recalls •

• Categories: Diagnostic Equipment, Other Medical Devices

The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.

Class I - Dangerous

Ingestible video capsule system has capsule with incorrect capture mode which will not record data when the capsule is ingested by patients. If used, there is a risk of delay of diagnosis and the patient may need to repeat the exam.

Feb 26, 2020 Diagnostic Equipment Nationwide View Details →

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 abnormalities of the small bowel.

Class I - Dangerous

Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.

Jul 3, 2019 Diagnostic Equipment Nationwide View Details →

CapsoCAM Plus, UDI: 00867770000209

Class I - Dangerous

Capsule Endoscopy System: a defect present in the capsule window may be stressed through the production process and in the final package, which could cause the housing of the capsule to crack and leak when ingested. Fluid from the patient could leak in to the capsule, which may damage components inside the capsule and the patient data may not be retrieved; the patient may need to repeat the exam.

Oct 18, 2019 Other Medical Devices Nationwide View Details →