Philips Healthcare Inc.: Medical Device Recall in 2012 - (Recall #: Z-2384-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 14, 2012

Date Posted: September 26, 2012

Recall Number: Z-2384-2012

Event ID: 62884

Reason for Recall:

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.

Status: Terminated

Product Quantity: 4 systems

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

Voluntary or Mandated:

Voluntary: Firm initiated