Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:34667
Brand Name:Ingenia, Achieva Series
Model:Philips MR systems with SW versions R11.1 and R12.1
Affected:
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 Nederland BV
Brand Name:PMS Nederland MR Systems
Model:Philips MR systems with SW versions R11.1 and R12.1
Affected:
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 Nederland BV
Issue:Issue 1. Image orientation incorrect (patient hands)
The manufacturer has identified that MRI images may display an incorrect orientation, where the patient's hands are reversed showing the left hand as the right and the right hand as the left.
Issue 2. Nurse call system pinch ball may not function.
The manufacturer has identified that the nurse call pinch ball may not function as intended, which is to alert the operator in cases of patient anxiety or discomfort. Pressing the nurse call pinch ball should activate a buzzer that can be heard as long as the ball is squeezed. When the pinch ball is pressed more than once within 4 seconds or for more than 1.5 seconds, a flashing yellow light should be activated in the control room to draw the operator's attention.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:13/2/2025
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