Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20091 |
| Brand Name: | Siemens Biograph TruePoint with PET syngo 6.7.x software AND Biograph mCT and mCT Flow systems |
| Model: | |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Siemens Healthcare (NZ) Ltd Millennium Centre, Part Level 2, Building A 600 Great South Road Ellerslie AUCKLAND 1051 |
| Contact Information: | 0800 310 300 |
| Manufacturer: | Siemens Medical Solutions USA Inc |
| Issue: | It has become aware, through customer complaint process, that utilizing a phantom other than the Siemens solid Germanium-68 phantoms may impact the Calibration Factor values generated during the PET Quality Control procedure. Depending on the type of uniform phantom utilized to perform the PET Quality Control, the PET Calibration Factor may be biased due to the system using a specific mu-value of 0.1 cm-1 which is based on the Siemens solid Germanium-68 phantom. The system will use this default mu-value, regardless of the actual mu-value of the phantom utilized for PET Quality Control; this may cause a variation in the quantification of the attenuation corrected PET images. |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/5/2016 |
