Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22197 |
| Brand Name: | Cleveland CT |
| Model: | |
| Affected: | The following CT(Computed Tomography) systems are affected: Brilliance 64 728231, Ingenuity Core128 728323, Ingenuity CT 728326 |
| Software version: | Running software version: 4.1.6 |
| Recalling Organisation: | Philips New Zealand Commercial Limited Level 3 123 Carlton Gore Road Newmarket AUCKLAND 1023 |
| Contact Information: | 0800 251 400 |
| Manufacturer: | Philips Medical Systems |
| Issue: | The manufacturer has become aware of a potential problem with our Philips Brilliance 64/ Ingenuity Family version 4.1.6 as detailed below: Issue 1: Cardiac Signal not found in Workflow Issue Issue 2: Scan may start at the top of the head, which may not be where the operator is expecting the scan to start Issue 3: Pulmo Gates on Cardiac Workflow Issue Issue 4: In the Plan viewer if the start position is modified the total length of the acquisition will changes as well. Issue 5: Image volumes are not found in patient directory when thin images are included in one of the multiple results Issue 6: Application may fail when modifying the results Plan Box during 3D Calcium Score Issue 7: Tube too hot Issue 8: Memory overflow Issue Issue 9: While the reconstruction is in progress disconnecting the Recon box (CIRS) may not give error message Issue 10: Issue with the GeneratorMonitor state machine in RHost code Issue |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 6/11/2017 |
