DuoDiagnost, model 707015, Universal RF system Product Usage: is a mult-functional diagnostic X-Ray system intended for Fluorosopic, Radiographic, Angiographic, and Interventional applications.
This recall has been terminated (originally issued March 16, 2012).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- December 26, 2011
- Posted
- March 16, 2012
- Terminated
- November 1, 2013
- Recall Number
- Z-1220-2012
- Quantity
- 2 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
USA Nationwide Distributed in Puerto Rico
Lot / Code Info
S/N: 07110582 and 09100826
Root Cause
No Marketing Application
Action Taken
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.