CapsoCam Plus SV-3Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K161773, K183192, K192662); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 18, 2019Terminated

   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.

   Z-1827-2020 · Root cause: Other · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161773, K183192, K192662. One submission often covers many models, so check the product and lot details in each record.

• Z-2536-2020 · Feb 26, 2020 · Terminated
  The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for visualization of the small bow
• Z-2073-2020 · Jul 3, 2019 · Terminated
  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