HIGH

Siemens Medical Solutions Recalls Fluoroscopic X-Ray System

Siemens Medical Solutions USA recalled 20 Artis Pheno. Image-Intensified Fluoroscopic X-Ray Systems due to limited system movements after startup. The recall, announced on August 12, 2025, affects devices distributed nationwide across several states.

Hazard Information

Limited system movements after startup .

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Siemens Medical Solutions USA, Inc or your healthcare provider for instructions. Notification method: Letter

Product Details

The recall involves the Artis Pheno. Image-Intensified Fluoroscopic X-Ray System, including model number 10849000 and serial numbers ranging from 164011 to 164188. These units were distributed in states including Alabama, Florida, New York, and Texas.

The Hazard

Users may experience limited movements of the system after startup, which can compromise patient safety and diagnostic effectiveness. This issue poses a high risk to patients and healthcare providers.

Reported Incidents

There are no reported injuries or incidents related to the limited movements of the system, but the potential for serious consequences remains.

What to Do

Stop using the device immediately. Contact Siemens Medical Solutions USA or your healthcare provider for further instructions.

Contact Information

For more information, call Siemens Medical Solutions USA at 1-800-XXX-XXXX or visit their website at www.siemens.com.

Key Facts

  • Recall date: August 12, 2025
  • Active recall status
  • Class II hazard classification
  • 20 units affected
  • Nationwide distribution across several states
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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeFluoroscopic X-Ray System
Sold At
Multiple Retailers

Product Details

Model Numbers
Model No. 10849000
UDI: 04056869046877
Serial No. 164184
164183
164071
+15 more
Affected States
ALL
Report Date
September 17, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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