Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00330-1
Product Name/Description Symbia E and 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