FDAClass IISeptember 26, 2012

Philips DigitalDiagnost Systems with M Cabinet recall

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

Why was Philips DigitalDiagnost Systems with M Cabinet recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
Recalling firm
Philips Healthcare Inc.
Quantity
4 systems
Distribution
Worldwide Distribution - USA including OH and WA and the country of Canada
Recall date
September 26, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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