—#107027

Product

DuoDiagnost, model 707015, Universal RF system Product Usage: is a mult-functional diagnostic X-Ray system intended for Fluorosopic, Radiographic, Angiographic, and Interventional applications.

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K983069
Affected lot / code info: S/N: 07110582 and 09100826

Why it was recalled

The device is currently not compliant with FDA's amended design criteria for this system, the product is not commercially available in the US. However, it was inadvertently shipped to Puerto Rico due to a logistical error.

Root cause (FDA determination)

No Marketing Application

Action the firm took

Philips sent an Urgent - Field Safety Notice dated December 26, 2011 to the two affected customers. The letter identified the affected product, problem description, hazard involved, actions to be taken by customer/user and actions planned by Philips. The letter states that customers may continue to use the DuoDiagnost system until the new systems are replaced by Philips. A Philips representative will contact customers to arrange for the replacement of current system. For further information or support contact your local Philips representative.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: USA Nationwide Distributed in Puerto Rico

Timeline

Recall initiated: 2011-12-26
Posted by FDA: 2012-03-16
Terminated: 2013-11-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107027. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.