[mdr] Digitaldiagnost, Digital Diagnost C90, 7300c

Recalling firm

Philips New Zealand Commercial Limited

Product

[MDR] DigitalDiagnost, Digital Diagnost C90, 7300C. [Device]. Model: Model number 712034: DigitalDiagnost C90 High Performance and Model number 712035: DigitalDiagnost C90 Flex/Value/Chest/ER. Affected: Software version - 1.1.7V20.4270.008

Reason

The manufacturer has identified multiple software problems affecting specific DXR systems. The problems have no associated safety impact but may affect the performance of the equipment., 1. The system may not enter a ready state for wall stand exposures when the Ceiling Suspension Motorised (CSM) Arm Swing is not in the locked position, preventing certain examinations from being performed as intended., 2. The Tube Control Handle (TCH) may intermittently restart, multiple times during start-up, resulting in delays before the system is available for clinical use., 3. Systems without a valid...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-08-04

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/794a714e-828b-4fc3-aa48-f33b3122ff56