Home / Recalls / Philips Electronics North America Corporation / Z-0330-2018

Z-0330-2018 Class II Terminated

Recalled by Philips Electronics North America Corporation — Andover, MA

Recall Details

Product Type
Devices
Report Date
January 17, 2018
Initiation Date
October 19, 2017
Termination Date
September 20, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10

Product Description

CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography

Reason for Recall

The tube adapter-plate green/yellow protective earthing (PE) wire was removed. and spacers with different thickness were used to position pre-loc ring in respect to focal spot in specified distance.

Distribution Pattern

Worldwide Distribution - US Distribution and to the countries of : France, Germany, Luxembourg and New Zealand.

Code Information

All CombiDiagnost R90 UDI 709030

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