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.
FDA Recall Z-2073-2020 · Posted None
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Recalling FirmCapso Vision, Inc.
Recall StatusTerminated
Product CodeNEZ
Date Initiated2019-07-03
Date Terminated2021-01-28
Product Quantity44 units
Reason for Recall
Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.
Firm Action
On 07/03/2019, the firm sent an "URGENT: Medical Device Voluntary Recall Letter" to customers via email informing them that this recall is being initiated due to the discovery of possible mis-labeling of the device packaging with an incorrect serial number label and that the firm is aware of one incident of incorrect serial number. Actions to be taken by customers are to ship back the affected capsules with serial numbers provided with the notification letter. Customer are asked to notify the Recalling Firm by email if they are experiencing inventory shortage and replacements will be shipped as soon as the firm is notified.
For any the Recalling Firm directly with any concerns or questions at (408) 866-6358 Monday through Friday, 8:00 AM to 4:30 PM (Pacific Time), or at email address [email protected]
Root Cause
Process control
Distribution Pattern
US Nationwide distribution including in the states of FL, GA, NY, PA, and TX.
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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