Recall Z-1827-2020 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
Capso Vision, Inc.
CapsoCAM Plus, UDI: 00867770000209
| Date | Oct 18, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | Starting on 10/18/19, Urgent Medical Device Voluntary Recall Letters were emailed to customers. Customers were asked return affected product and to complete the Return Material Authorization form. The recalling firm asked distributors to provide their latest shipment lists. |
| Quantity | 1882 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183192 | CapsoCam Plus (SV-3) CapsoVision, Inc., Apr 19, 2019 |