Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    model numbers: 10091805, 10091806, 10091807, 10091673 with serial numbers: 85170 85250 85188 85191 85198 85151 85165 85241 85130 85163 85019 85287 85298 85202 85168 85068 85206 85280 85235 85195 85194 85123 85199 85364 85282 85275 85115 85062 85067 85080 85216 85218 85177 85242 85248 85237 85284 85329 85259 85279 85230 85192 85277 85278 85178 85220 85157 85114 85268 85134
  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:
Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.

Product Codes/Lot Numbers:

model numbers: 10091805, 10091806, 10091807, 10091673 with serial numbers: 85170 85250 85188 85191 85198 85151 85165 85241 85130 85163 85019 85287 85298 85202 85168 85068 85206 85280 85235 85195 85194 85123 85199 85364 85282 85275 85115 85062 85067 85080 85216 85218 85177 85242 85248 85237 85284 85329 85259 85279 85230 85192 85277 85278 85178 85220 85157 85114 85268 85134

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1613-2014

Related Recalls

MAMMOMAT Inspiration;

Siemens Medical Solutions USA

Class I - Dangerous

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

Oct 24, 2025 Other Medical Devices Nationwide View Details →

MAMMOMAT Fusion;

Siemens Medical Solutions USA

Class I - Dangerous

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

Oct 24, 2025 Other Medical Devices Nationwide View Details →

MAMMOMAT Revelation;

Siemens Medical Solutions USA

Class I - Dangerous

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

Oct 24, 2025 Other Medical Devices Nationwide View Details →