Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00330-1
Product Name/Description	Symbia E and e.cam collimator (nuclear imaging gamma camera system) Catalogue Numbers: 10275879, 10413009, 04380213, 04380221, 05242826, 05977066, 05977074, 05984005, 05989079, 05989087, 05989095, 05991109, 05991117, 05992099, 07324119, 07324135, 07324143, 07324150, 07760809, 07760932, 07761161, 07823920, 07823938, 07823946, 07823953, 07823961, 07823979, 10151531, 10151532, 10520745 ARTG Number: 186317
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	21/03/2016
Responsible Entity	Siemens Healthcare Pty Ltd
Reason/Issue	Siemens have received complaints regarding incidents where collimator change activities have resulted in operator injury. The investigation found that these incidents may have been avoided by operators properly following specified instructions. The system was designed to safely store and exchange collimators, however if the instructions are not followed serious injuries, such as broken bones and lacerations, may occur. Siemens have determined that although the existing user manual is correct, additional supplemental instructions, with the inclusion of visual aids, may further clarify and emphasise the proper collimator change process.
Recall Action	Recall for Product Correction
Recall Action Instructions	Siemens is providing users with addendum instructions to follow during collimator change activities. This action has been closed-out on 27/01/2017.
Contact Information	1800 310 300 - Siemens Technical Support Centre