FDAFDA · Food and drugs·Recall number Z-2384-2012
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
Published September 26, 2012 · Recall initiated: August 14, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Philips Healthcare Inc.
- Distributor
- Worldwide Distribution - USA including OH and WA and the country of Canada
- Lot
- Lot or Serial Numbers With affected M-cabinet CXA; Serial number; 11-K0003; 12-B0001, 12-B0002; 12-B0003
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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