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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