Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-01008-1
Product Name/Description	PillCam Express Delivery Device (Indicated for the transendoscopic delivery of the PillCam SB video capsule in patients who are unable to ingest the PillCam capsule or are known to have slow gastric emptying time) Part Numbers: FGS-0366 & FGS-0367 Batch Numbers: 15720 to 18568 Supplied between August 2010 and July 2012 ARTG Number: 174813
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	28/09/2012
Responsible Entity	Given Imaging Pty Limited
Reason/Issue	Given Imaging has received reports of failures of the PillCam during normal use and when the product was used in a manner that was not supported by its design specifications and tolerance's.
Recall Action	Recall
Recall Action Instructions	Given Imaging is recalling all affected devices and ceasing supply. There are alternative products available for customers.
Contact Information	02 9889 3944 - Given Imaging