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Lower risk Medical device recall · FDA · Published December 21, 2018

Philips DigitalDiagnost C5: Missing Label Recall - Safety Notice

Philips recalls DigitalDiagnost C50 X-ray systems due to a missing label. This may affect safety and compliance. Contact Philips for details.

🇺🇸 FDA recall #Z-2498-2019Medical devicePhilips Healthcare ›
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Contact the company

Call(800) 722-9377
Recalling firmPhilips Healthcare3000 Minuteman Rd · Andover, MA 01810-1032
✎ GovInfoNow plain-language explainer

What happened, in plain English

Philips Healthcare is recalling its DigitalDiagnost C50 stationary X-ray systems because a critical label is missing. This could lead to safety and compliance issues if the label is not present. Read more at govinfonow.com/recall/69263-philips-digitaldiagnost-c5-missing-label-recall-safety-notice.

Source Summary by GovInfoNow · govinfonow.com/recall/69263-philips-digitaldiagnost-c5-missing-label-recall-safety-notice · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2498-2019

Cite this page

“Philips DigitalDiagnost C5: Missing Label Recall - Safety Notice.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69263-philips-digitaldiagnost-c5-missing-label-recall-safety-notice. Based on FDA recall #Z-2498-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2498-2019%22&limit=1).

Why it’s dangerous

The missing label could cause safety and compliance issues. Without the label, the system might not meet required standards for proper operation and safety.

Who’s affected

Healthcare facilities using Philips DigitalDiagnost C50 X-ray systems are likely affected. Staff and patients using these systems may be at risk if the label is missing.

How to tell if you have this one

Check for the product name 'DigitalDiagnost C50' and product number 712201 on the system. The system serial numbers are SN170053 or SN180074.

  • Brand
    Philips Healthcare
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check for Missing Label

    Look for the label that was identified as missing in the recall notice.

Where it went and when

Where it was distributed

Distributed in Puerto Rico.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFLPuerto Rico: yesPR

FDA distribution: “Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Puerto Rico.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

1. Firm started the recall: Dec 21, 201812. FDA classified it Class II: Sep 20, 201923. Published in FDA’s Enforcement Report: Oct 2, 201934. FDA terminated the recall: Oct 27, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Take action

Contact Philips Healthcare

We’ve drafted a message you can send Philips Healthcare to request your refund or repair — edit it as you like.

Subject: Recall Z-2498-2019 — Philips Healthcare Philips DigitalDiagnost C5: Missing Label Recall - Safety Notice

Hello,

I own a Philips DigitalDiagnost C5: Missing Label Recall - Safety Notice that is covered by recall Z-2498-2019 from Philips Healthcare.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2498-2019 (December 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2498-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA