Saratoga, CA, United States
Capso Vision, Inc. recalls
3 recalls recorded since 2018, most recently on 26 February 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 26 February 2020
- Terminated
- 28 January 2021
- Reason
- 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.
- Distribution
- US Nationwide distribution including in the states of AZ, CA, DE, MD, NJ, NY, SC, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2536-2020
- 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
Terminated Class II Medical devices
- Recall started
- 18 October 2019
- Terminated
- 8 January 2021
- Reason
- Capsule Endoscopy System: a defect present in the capsule window may be stressed through the production process and in the final package, which could cause the housing of the capsule to crack and leak when ingested. Fluid from the patient could leak in to the capsule, which may damage components inside the capsule and the patient data may not be retrieved; the patient may need to repeat the exam.
- Distribution
- U.S.: CA, TX, FL, VA, PA, SC, HI, DC, NJ, UT, LA. Foreign: FR, AR, IT, UK, BE, TC, AU, CO, GM, GR, SP, SI, HR, MO, SW, EZ.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1827-2020
- CapsoCAM Plus, UDI: 00867770000209
Terminated Class II Medical devices
- Recall started
- 3 July 2019
- Terminated
- 28 January 2021
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2073-2020
- 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 muc
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.