Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15027 |
| Brand Name: | Philips Briiliance (BR) CT 16-Slice, BR CT 10-Slice Water, BR CT 6-Slice Water, MX8000 Quad, MX8000 Dual, MX8000 Dual EXP, MX8000 IDT and MX8000 IDT 10 |
| Model: | All models |
| Affected: | All serial numbers |
| Software version: | |
| 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 CT system phantom supplied with the above-listed scanners has a special pin by which the customer can check the Low Contract (LC) detectability for quality assurance. This pinconsists of a Nylon (Aculon) body with six smaller Lexan pins of 3mm, 4mm, 5mm, 6mm, 7mm and 8mm diameters, which have contrast difference of approximately 1% from Aculon. The LC test is performed by visually inspecting the sectionand selecting the smallest detectable Lexan pin for a predefined scan protocol as defined in the instructions for use. The manufacturer-recommended procedure is subjective in nature and needs to be performed on several scans and by different people to be reliable. The pin visibility deteriorates over time because of slow water absorption. As the pin visibility deteriorates the test becomes unreliable and inaccurate. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/7/2013 |
