Class 2 Device Recall CapsoCam Plus (SV3)

• Date Initiated by Firm: July 03, 2019
• Create Date: May 21, 2020
• Recall Status: Terminated on January 28, 2021
• Recall Number: Z-2073-2020
• Recall Event ID: 85532
• 510(K)Number: K183192
• Product Classification: System, imaging, gastrointestinal, wireless, capsule - Product Code NEZ
• 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Capso Vision, Inc.; 18805 Cox Ave Ste 250; Saratoga CA 95070-6615
• For Additional Information Contact: Azimun Jamal; 408-866-6358
• Manufacturer Reason for Recall: Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.
• FDA Determined 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 azimun.jamal@capsovision.com
• Quantity in Commerce: 44 units
• Distribution: US Nationwide distribution including in the states of FL, GA, NY, PA, and TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NEZ