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Terminated

CapsoCAM Plus, UDI: 00867770000209

FDA Recall Z-1827-2020 · Posted None

Recalling FirmCapso Vision, Inc.
Recall StatusTerminated
Product CodeNEZ
Date Initiated2019-10-18
Date Terminated2021-01-08
Product Quantity1882

Reason for Recall

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K183192CapsoCam Plus (SV-3)CapsoVision, Inc. · 2019-04-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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