Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18526 |
| Brand Name: | Philips AFFINITI 70 Ultrasound System, without Pediatric Cardiology option |
| Model: | AFFINITI 70 |
| Affected: | |
| Software version: | 1.0.2 or lower without the Pediatric Cardiology |
| Recalling Organisation: | Philips New Zealand Commercial Limited Level 3 123 Carlton Gore Road Newmarket AUCKLAND 1023 |
| Contact Information: | 0800 251 400 |
| Manufacturer: | Philips Ultrasound LLC |
| Issue: | When AFFINITI 70 Ultrasound System is set up to 'Metric' and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patient's Body Surface Area (BSA). Using patient's weight only to calculate the BSA, which is the usual practice for patients under the age of 2 years, would result in a value that is too high by a factor of about 1.7. A Cardiac Index calculated using that value would be too low by a factor of 1.7. An error of this magnitude may not be readily detected by the user. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/5/2015 |
