Z-2073-2020Class II

CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF...

Name: Z-2073-2020 CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF...
Creator: Capso Vision, Inc.
Published: 2019-07-03
License: https://open.fda.gov/license/

CapsoVision, Inc. / initiated 2019-07-03 / Terminated / root cause: manufacturing process

FDA source

Capso Vision, Inc. began a recall of CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video... on 2019-07-03. FDA classified it as Class II and gives the reason as "Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2073-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-03
Posted: 2020-05-21
Terminated: 2021-01-28
Recalling firm: CapsoVision, Inc.
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.
Product code: NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Reason for recall: Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.
Root cause tag: manufacturing process
FDA 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 as soon as the firm is notified. For any the Recalling Firm directly with any concerns or questions at (408) 866-6358 Monday through Friday, 8:00 AM to 4:30 PM (Pacific Time), or at email address [email protected]
Quantity in commerce: 44 units
Distribution: US Nationwide distribution including in the states of FL, GA, NY, PA, and TX.
Product codes and lots: Lot Number: 02-18-0036 Serial Number and UDI Codes: A00ZD4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZD4.699; A00ZJ2.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZJ2.699; A00ZK2.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZK2.699; A00ZM0.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZM0.699; A00ZM3.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZM3.699; A00ZN3.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZN3.699; A00ZQ5.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZQ5.699; A00ZW6.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZW6.699; A01004.699 0100867770000209 13180921 17200921 1002-18-0036 21A01004.699; A0100H.699 0100867770000209 13180921 17200921 1002-18-0036 21A0100H.699; A0102J.699 0100867770000209 13180921 17200921 1002-18-0036 21A0102J.699; A0104G.699 0100867770000209 13180921 17200921 1002-18-0036 21A0104G.699; A0104U.699 0100867770000209 13180921 17200921 1002-18-0036 21A0104U.699; A00ZD6.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZD6.699; A00ZJ5.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZJ5.699; A00ZK4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZK4.699; A00ZX4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZX4.699; A010AA.699 0100867770000209 13180921 17200921 1002-18-0036 21A010AA.699; A00ZL7.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZL7.699; A00ZL8.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZL8.699; A0102T.699 0100867770000209 13180921 17200921 1002-18-0036 21A0102T.699 A010A8.699 0100867770000209 13180921 17200921 1002-18-0036 21A010A8.699; A010TD.699 0100867770000209 13180921 17200921 1002-18-0036 21A010TD.699; A00ZY5.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZY5.699; A010QP.699 0100867770000209 13180921 17200921 1002-18-0036 21A010QP.699; A010T9.699 0100867770000209 13180921 17200921 1002-18-0036 21A010T9.699; A010UC.699 0100867770000209 13180921 17200921 1002-18-0036 21A010UC.699; A00ZL4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZL4.699; A00ZN4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZN4.699; A00ZP5.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZP5.699; A00ZQ4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZQ4.699; A00ZW9.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZW9.699; A00ZY1.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZY1.699; A00ZY4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZY4.699; A00ZY6.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZY6.699; A00ZZ7.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZZ7.699; A010N1.699 0100867770000209 13180921 17200921 1002-18-0036 21A010N1.699; A00ZC7.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZC7.699; A00ZG3.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZG3.699; A00ZX7.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZX7.699; A010PH.699 0100867770000209 13180921 17200921 1002-18-0036 21A010PH.699; A00ZC2.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZC2.699; A00ZC6.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZC6.699; A00ZH4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZH4.699

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2073-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2073-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21

Product code NEZ

K183192Class IICapsoCam Plus (SV-3)CapsoVision, Inc. / cleared 2019-04-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)