FDA-Device2023-05-10Class II

Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system

Philips North America Llc
Hazard

Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a cable located under the tabletop that is covered by a plastic sleeve which can crack and damage the cable. If the tabletop cable breaks, the user may not be able to initiate table tilting movements or braking

Sold states
Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Chile, China, Germany, India, Italy, Malaysia, Netherlands, Panama, Spain, Thailand.
Affected count
Total Quantity: 234 units. US 195units. R.O.W 39 units
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1477-2023

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