FDA recall Z-1477-2023

Philips North America Llc · Class II · device

Product

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

Reason for recall

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

Distribution

Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Chile, China, Germany, India, Italy, Malaysia, Netherlands, Panama, Spain, Thailand.

Key facts

Status: Ongoing
Initiation date: 2022-10-21
Report date: 2023-05-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cambridge, MA, United States

Primary source

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