FDA Medical Device Recalls (openFDA)
Philips Healthcare: DigitalDiagnost C50, Stationary X-ray System
- Recall number
- Z-2498-2019
- Recalling firm
- Philips Healthcare
- Product
- DigitalDiagnost C50, Stationary X-ray System
- Status
- Terminated
- Initiated
- 2018-12-21
- Posted
- not on file
- Terminated
- 2020-10-27
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- 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.
- Quantity
- 2
- Distribution
- Puerto Rico
- Lot, serial or model codes
- Product Number 712201 System Serial Number: SN170053 SN180074
- 510(k) numbers
- ["K163410"]
- PMA numbers
- not on file
- Product code
- KPR
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28