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