FDA-Device2023-04-19Class II
Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
Philips North America Llc
Hazard
If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, and may result in injuries to patients and users
Sold states
Nationwide including Puerto Rico and Virgin Islands Foreign: ARGENTINA Australia Austria Bosnia and Herzegovina Bulgaria China Colombia Cyprus Czech Republic Egypt France French Polynesia Germany Greece Hungary Indonesia Italy Jordan Kenya Latvia Lithuania Macedonia Malta Mexico Netherlands New Zealand Philippines Poland Portugal Puerto Rico Russian Federation Saudi Arabia Serbia Slovenia South Africa Spain Sri Lanka Switzerland Tanzania Thailand United Arab Emirates Viet Nam Yemen
Affected count
US: 10 units; OUS: 570 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1382-2023Don't want to check this manually?
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