FDA recall Z-2498-2019

Product

DigitalDiagnost C50, Stationary X-ray System

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.

Distribution

Puerto Rico

Key facts

Status

Terminated

Initiation date

2018-12-21

Report date

2019-10-02

Termination date

2020-10-27

Voluntary/Mandated

FDA Mandated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2498-2019