Recall Z-2536-2020— Capso Vision, Inc.

Name: FDA recall Z-2536-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-26

Class II · Terminated

Class II FDA medical device recall by Capso Vision, Inc., initiated 2020-02-26, terminated 2021-01-28. It names one FDA 510(k) clearance: K192662. Product: 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.. Reason: 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..

Recalling firm: Capso Vision, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-02-26
Terminated: 2021-01-28
Firm location: Saratoga, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K192662 — CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc.·cleared 2020-02-14

K-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

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.