Recall Z-2498-2019— Philips Healthcare
Class II · Terminated
Class II FDA medical device recall by Philips Healthcare, initiated 2018-12-21, terminated 2020-10-27. It names one FDA 510(k) clearance: K163410. Product: DigitalDiagnost C50, Stationary X-ray System. Reason: 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..
- Recalling firm
- Philips Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-21
- Terminated
- 2020-10-27
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.