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.
FDA Recall Z-2536-2020 · Posted None
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Recalling FirmCapso Vision, Inc.
Recall StatusTerminated
Product CodeNEZ
Date Initiated2020-02-26
Date Terminated2021-01-28
Product Quantity82
Reason for Recall
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.
Firm Action
Beginning 02/26/2020, the firm notified affected customers via email of "URGENT: Medical Device Voluntary Recall Letter". The letter indicated, as soon as the customer receives the notice, please provide acknowledgment of receipt. The letter requested actions to be taken by the customer/user: We request that you ship back the affected capsules using the provided RMA form and return shipping label. For any concerns or question email or contact the firm at (408) 866-6358.
Root Cause
Employee error
Distribution Pattern
US Nationwide distribution including in the states of AZ, CA, DE, MD, NJ, NY, SC, and VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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