Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21085 |
| Brand Name: | Philips Brightview XCT |
| Model: | |
| Affected: | BrightView XCT |
| 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 manufacturer intends to release a revision of the Instruction For Use with an amendment to the intended use. The amendment is the result of a mismatch of intended use between the IFU released globally & the 510 (k) regulatory submission in the US. The claims in the labelling describe additional functional capabilities of the system, which while not cleared in the US, remain accurate and supported by the manufacturer. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 10/2/2017 |
