Capso Vision, Inc. recalls CapsoCAM Plus, UDI: 00867770000209

Recall date

October 18, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1827-2020

FDA classification

Class II

Brand / firm

Capso Vision, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CapsoCAM Plus, UDI: 00867770000209