—#160799

Product

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

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K163210
Affected lot / code info: All CombiDiagnost R90 UDI 709030

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Philips Medical System sent an Customer Notification letter dated October 19, 2017, and plans to have a Philips Field Service Engineer go to site to perform the field change order (FCO70900041) including: 1. Check for the presence of the PE cable and, if missing, install it. 2 .Perform a modified screw fixation. They expect to complete action by May 2018. For further questions, please call (978) 659-3000.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

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

Timeline

Recall initiated: 2017-10-19
Terminated: 2018-09-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160799. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.