FDA recall Z-2073-2020

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 for recall

Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.

Distribution

US Nationwide distribution including in the states of FL, GA, NY, PA, and TX.

Key facts

Status

Terminated

Initiation date

2019-07-03

Report date

2020-05-27

Termination date

2021-01-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saratoga, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2073-2020