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Terminated

Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system

FDA Recall Z-0522-2018 · Posted None

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2017-11-01
Date Terminated2018-08-14
Product Quantity2

Reason for Recall

One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.

Firm Action

Philips Healthcare is notifying the affected users of this issue via this Customer Information Letter and correcting via Field Change Order FC088200514.

Root Cause

Vendor change control

Distribution Pattern

One domestic and 1 foreign consignee ( Spain)

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052640GEMINI RAPTORPhilips Medical Systems (Cleveland), Inc. · 2005-10-07

Official Source

View FDA Recall →

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

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