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Terminated

DigitalDiagnost C50, Stationary X-ray System

FDA Recall Z-2498-2019 · Posted None

Recalling FirmPhilips Healthcare
Recall StatusTerminated
Product CodeKPR
Date Initiated2018-12-21
Date Terminated2020-10-27
Product Quantity2

Reason for Recall

During recent evaluations of the Philips DigitalDiagnost C50 system, Philips identified a missing label. This notification is intended to provide you with information regarding what the issue is, and relevant affected product, the actions you are required to take and the actions planned by Philips to correct the issue. If you need any or further information or support concerning this issue, please contact your local Philips representative or Philips Customer Service: 1-800-722-9377.

Firm Action

Philips plans to initiate a field corrective action that will install the required label(s). Philips will implement the correction at no cost to the customer.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Puerto Rico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K163410DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · 2017-01-04

Official Source

View FDA Recall →

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

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