[mdr] Radiography 7000 M

Radiography 7000 M Recall Summary Philips is recalling the Radiography 7000 M X-ray system (model with Software release R1.0.3, product number 712010) distributed to hospitals and laboratories in New Zealand. The device may display an incorrect "Filter selection failure" error message when switching between examinations, which prevents X-ray exposures from being taken even though the filter is working properly. This is a Class I recall, the most serious classification.

Recalling firm
Philips New Zealand Commercial Limited
Product
[MDR] Radiography 7000 M. [Device]. Model: Radiography 7000M with Software release R1.0.3. Affected: Product number: 712010
Reason
The manufacturer has identified that when the operator is switching between examinations, an intermittent software failure may cause the console to display the message "Call service! Filter selection failure. This display message may appear even if the motorized filter has been selected correctly. If this happens, the system enters a Not Ready state and does not permit an X-ray exposure.
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-10-12
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/de17b104-6d9d-4235-bfb6-9c916d224c20