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.
Reported: July 15, 2020 Initiated: February 26, 2020 #Z-2536-2020
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.
Details
- Recalling Firm
- Capso Vision, Inc.
- Units Affected
- 82
- Distribution
- US Nationwide distribution including in the states of AZ, CA, DE, MD, NJ, NY, SC, and VA.
- Location
- Saratoga, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Capso Vision, Inc.. Units affected: 82.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 15, 2020. Severity: Moderate. Recall number: Z-2536-2020.
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