Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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 tool in the detection of abnormalities of the small bowel.

U.S. FDA — Device Enforcement · United States · 2020-02-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2536-2020
Date of alert: 2020-02-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Capso Vision, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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