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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01052-1
Product Name/Description e.cam and Symbia E systems
(Nuclear medicine gamma camera system)

Catalogue Numbers: 4380213, 4380221, 5242826, 5977066, 5977074, 5984005, 5989079, 5989087, 5989095, 5991109, 5991117, 5992099, 7324119, 7324135, 7324143, 7324150, 7760809, 7760932, 7761161, 7823920, 7823938, 7823946, 7823953, 7823961, 7823979, 10151531, 10151532, 10275879, 10413009, 10520745

ARTG Numbers: 186317, 186317
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 10/08/2016
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue Siemens has received reports of patients’ hair being caught in the e.cam and Symbia E patient bed up/down drive. Siemens is reminding users of the patient positioning instructions for the e.cam or Symbia E systems. Additionally, an enhancement kit that reduces the gap in the patient bed up/down drive has been designed and will be installed by Siemens.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is reminding users of the positioning instructions for the e.cam and Symbia E systems that require operators to properly position the patient and observe the patient at all times. Siemens will be arranging for an enhancement kit to be installed by a Siemens service representative. This action has been closed-out on 23/06/2017.
Contact Information 1800 310 300 - Siemens Customer Care Centre