CLASS II Device recall · Reported 2 Oct 2019 · FDA Enforcement Report

DigitalDiagnost C50, Stationary X-ray System recalled

Philips Healthcare is recalling DigitalDiagnost C50, Stationary X-ray System, distributed in Puerto Rico. The recall was initiated on 21 Dec 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Number 712201 System Serial Number: SN170053 SN180074

Quantity recalled2

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2498-2019
FDA event ID: 83654
Recalling firm: Philips Healthcare, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 21 Dec 2018
FDA classified: 20 Sep 2019
Reported: 2 Oct 2019
Type: FDA Mandated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Imaging Equipment

Timeline

21 Dec 2018	Recall initiated by company
20 Sep 2019	Classified by FDA	+273 days
2 Oct 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

DigitalDiagnost C50, Stationary X-ray System

Where it was distributed

Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

Product Number 712201 System Serial Number: SN170053 SN180074

Where was it sold?

Puerto Rico

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Philips Healthcare

All 57

Reported	Class	Recall	Company	Reason	Where
11 Oct 2023Device	CLASS II	Incisive CT recalled by Philips Healthcare	Philips Healthcare	Processing Deviation	Nationwide
13 Apr 2022Device	CLASS II	Philips StentBoost Live R2.0 application, when used recalled	Philips Healthcare	Device Malfunction	Nationwide
30 Mar 2022Device	CLASS II	Azurion systems recalled by Philips Healthcare	Philips Healthcare	Device Malfunction	Nationwide
1 Dec 2021Device	CLASS II	ProxiDiagnost N90 is multi-functional general R/F systems recalled	Philips Healthcare	Other	Nationwide
1 Dec 2021Device	CLASS II	Philips Azurion systems recalled by Philips Healthcare	Philips Healthcare	Device Malfunction	Nationwide

Other Imaging Equipment recalls

All 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled	Canon Medical System USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederl	Potency & Assay