Capso Vision Recalls
3 recalls on record · May 6, 2020 to July 15, 2020 · Medical Devices
July 15, 2020Medical DevicesFDA
Capso Vision, Inc. recalls The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795
Hazard: 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.
May 27, 2020Medical DevicesFDA
Capso Vision, Inc. recalls CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Produc
Hazard: Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.
May 6, 2020Medical DevicesFDA
Capso Vision, Inc. recalls CapsoCAM Plus, UDI: 00867770000209
Hazard: 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.