Health product recall

Reflux Software V6.1 (2019-09-18)

Starting date:
September 18, 2019
Posting date:
December 6, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-71794

Last updated: 2019-12-06

Affected Products

Reflux Software V6.1

Reason

Bravo event upload issue (bughost bug# 379) was reported from the field post product launch of reflux software. The issue is associated with a defect in Reflux Software version 6.1. For some bravo uploads, the meal and supine events data uploaded in Reflux SW 6.1 may be incorrect. Some unexpected events are being presented in the software. These events start from the very beginning of the study and are atypically long.

Affected products

Reflux Software V6.1

Lot or serial number

V 6.1

Model or catalog number

FGS-0656

Companies
Manufacturer
GIVEN IMAGING INC,
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES