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Terminated

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 Recall Z-0330-2018 · Posted None

Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeJAA
Date Initiated2017-10-19
Date Terminated2018-09-20
Product Quantity10

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.

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K163210Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH · 2017-01-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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