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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00419-1
Product Name/Description and all Symbia systems with foresight detectors (Nuclear medicine gamma camera systems)

Catalogue Numbers: 10151532, 8717733, 10275009, 10275010, 10275879, 8717741, 10275008, 10275007, 10764804, 10764803, 10764801, 10764802, 10910501, 10151531

ARTG Number: 186317
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 11/04/2016
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue Siemens has determined that or Symbia Systems with foresight detectors performing gated or dynamic acquisitions may lose some detector time-information. The resulting risk is that the framing of the image data and the calculated ejection fraction values may be lower. Although misdiagnosis could be possible if ejection fraction values are used as a sole input to diagnosis. In the lifetime of the product, Siemens have received three complaints, none of which led to misdiagnosis or adverse events.
Recall Action Recall for Product Correction
Recall Action Instructions A software patch (Ml16-001) and corresponding operator manual addendum will be implemented. Once the software patch is installed on the affected system, the improvements will further reduce the likelihood of the issue occurring. In the interim, users are advised they may continue to use your system since the probability of occurrence is remote. To reduce the likelihood of this issue, they are advised to perform Daily Shutdown and Start-up as described in the operator manual. This action has been closed-out on 26/05/2017.
Contact Information 1800 310 300 - Siemens Technical Support Centre