Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Given Diagnostic System with PillCam SB Capsule - Gastrointestinal capsule imaging system. The device is an ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.

FDA Recall Z-1447-2008 · Posted 2008-08-20

Recalling FirmGiven Imaging Inc
Recall StatusTerminated
Product CodeNEZ
Date Initiated2007-12-13
Date Terminated2010-11-15
Product Quantity1392 units

Reason for Recall

The cards included in the product's education kit (proposing a clinical algorithm for capsule endoscopy in patients with suspected Crohn's disease), were printed incorrectly.

Firm Action

Consignees were notified by letter on 12/13/2007. The letter contains a diagram illustrating the error on the incorrect card and a diagram illustrating the corrected card. Consignees were instructed to discard the incorrect card if they still have it and to complete a response form and return it via fax to Given Imaging.

Root Cause

Employee error

Distribution Pattern

Worldwide Distribution --- US including Puerto Rico and country of Canada

Official Source

View FDA Recall →

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

↑