CapsoCam Plus *** System recall: Labeling Error
CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus…
Why was CapsoCam Plus *** System recalled?
Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus…
- Recalling firm
- Capso Vision, Inc.
- Quantity
- 44 units
- Distribution
- US Nationwide distribution including in the states of FL, GA, NY, PA, and TX.
- Recall date
- May 27, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)