Syngo.plaza, Picture Archiving and Communication System

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 100262 100198 100258 100259 100538 100133 100213 100214 100031 100484 100362 100416 100461 100457 100447 100139 100027 100559 100440 100441 100025 100084 100186 100189 100190 100191 100192 100195 100196 100033 100232 100449 100450 100199 100256 100228 100425 100029 100253 100203 100204 100132 100434 100491 100495 100206
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Siemens Medical Solutions USA, Inc
Reason for Recall:
Software upgrade to eliminate several issues
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Syngo.plaza, Picture Archiving and Communication System

Product Codes/Lot Numbers:

Serial Numbers: 100262 100198 100258 100259 100538 100133 100213 100214 100031 100484 100362 100416 100461 100457 100447 100139 100027 100559 100440 100441 100025 100084 100186 100189 100190 100191 100192 100195 100196 100033 100232 100449 100450 100199 100256 100228 100425 100029 100253 100203 100204 100132 100434 100491 100495 100206

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2891-2016

Related Recalls

During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

Mar 9, 2026 Other Medical Devices View Details →
Class I - Dangerous

During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

Mar 9, 2026 Other Medical Devices View Details →

ARTIS Pheno VE30A and VE40A, Model 10849000

Siemens Medical Solutions USA

Class I - Dangerous

During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.

Mar 12, 2026 Other Medical Devices View Details →