Philips North America: System, X-ray, Mobile

Recall Summary Philips North America is recalling model 712010 mobile X-ray systems because the device may fail immediately after taking an X-ray exposure, leaving the system unable to move. This recall affects units distributed across all U.S. states and multiple countries worldwide. The FDA has classified this as a Class II recall.

Recalling firm
Philips North America
Product
Model Number: 712010.
Reason
Potential for the device to fail immediately after an exposure, causing the system to remain stationary.
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-09-18
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Worldwide Distribution: (US Nationwide) and International distribution to Angola, Australia, Austria, Canada, Chile, Cook Islands, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Honduras, Israel, Italy, Latvia, Lithuania, Macedonia, Namibia, Netherlands, New Zealand, Poland, Portugal,...

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/4457abcf-29c7-4b00-987d-c47f667e00fa