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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01177-1
Product Name/Description Welch Allyn Schiller AG 1500 Monitor (multi parameter patient monitor)

ARTG Number: 181948
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 29/11/2012
Responsible Entity Welch Allyn Australia Pty Limited
Reason/Issue Welch Allyn has advised that they inadvertently shipped the incorrect User Manual and Quick Reference guide for the Welch Allyn 1500 Monitor, which did not include some additional functions available in the device, which include Cardiac Output, hemodynamin and Integrated Pulmonary Index (IPI).
Recall Action Recall for Product Correction
Recall Action Instructions Updated Instructions for Use (IFU) will be issued.
Contact Information 02 9638 3000 - Welch Allyn Technical Support