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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01388-1
Product Name/Description Compella Air Surfaces Bed System (220 - 240 V, 50 Hz), used in conjunction with International 220 - 240 V, 50 Hz Controllers

Serial Numbers: CR600003 to CR604302 and CU200002 to CU200072

Manufacturing date range is from March 2015 – March 2017

ARTG Numbers: 239273 and 239274
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 6/11/2017
Responsible Entity Hill-Rom Pty Ltd
Reason/Issue Hill-Rom has become aware of a potential issue with some International (220 - 240 V, 50 Hz) Compella Air Surfaces. Within the Low Air Loss mattress, a hose in the foot section is prone to kinking and occluding air flow. This can result in heat rising and failure of the air compressor inside the Compella Controller. If the compressor fails, the Controller can no longer function correctly to maintain air flow to the Compella mattress, in which case the Controller will alarm. To date, there have been no reported patient safety related complaints associated with this issue.
Recall Action Recall for Product Correction
Recall Action Instructions Hill-Rom is advising users that the affected systems will be corrected as a permanent fix. The systems can continue to be used until the correction has been completed.

This action has been closed out on 05/11/2018
Contact Information 1800 445 576 - Hill-Rom Technical Support