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Recall Observatory FDA recall evidence

Device product

Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications

Z-2384-2012

August 14, 2012

Class II

Product summary

Firm
Philips Healthcare Inc.
Event
Event 62884
Status
Terminated
Classification
Class II
Quantity
4 systems
Official record key
device-enforcement:Z-2384-2012

Official wording

Reason: 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.

Code information: Lot or Serial Numbers With affected M-cabinet CXA; Serial number; 11-K0003; 12-B0001, 12-B0002; 12-B0003

Distribution pattern: Worldwide Distribution - USA including OH and WA and the country of Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.