Recall Z-2073-2020— Capso Vision, Inc.
Class II · Terminated
Class II FDA medical device recall by Capso Vision, Inc., initiated 2019-07-03, terminated 2021-01-28. It names one FDA 510(k) clearance: K183192. Product: 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.. Reason: Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis..
- Recalling firm
- Capso Vision, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-03
- Terminated
- 2021-01-28
- Firm location
- Saratoga, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.
Data sourced from openFDA. This site is unofficial and independent of the FDA.