Recall Z-2073-2020 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Capso Vision, Inc.
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.
| Date | Jul 3, 2019 |
| Status | Terminated |
| Reason | Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis. |
| Root cause | Process control |
| 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 |
| Quantity | 44 units |
| Distribution | US Nationwide distribution including in the states of FL, GA, NY, PA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183192 | CapsoCam Plus (SV-3) CapsoVision, Inc., Apr 19, 2019 |