Z-2498-2019Class II

DigitalDiagnost C50, Stationary X-ray System

Name: Z-2498-2019 DigitalDiagnost C50, Stationary X-ray System
Creator: Philips Healthcare
Published: 2018-12-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-12-21 / Terminated / root cause: labeling and UDI

FDA source

Philips Healthcare began a recall of DigitalDiagnost C50, Stationary X-ray System on 2018-12-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2498-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-21
Posted: 2019-09-20
Terminated: 2020-10-27
Recalling firm: Philips North America LLC
Product: DigitalDiagnost C50, Stationary X-ray System
Product code: KPR System, X-Ray, Stationary
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 2
Distribution: Puerto Rico
Product codes and lots: Product Number 712201 System Serial Number: SN170053 SN180074

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2498-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2498-2019	Class II	Terminated	FDA Mandated	2019-10-02	2019-09-20

Product code KPR

K163410Class IIDigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. / cleared 2017-01-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)