Recall Z-1220-2012 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips Healthcare Inc.
DuoDiagnost, model 707015, Universal RF system Product Usage: is a mult-functional diagnostic X-Ray system intended for Fluorosopic, Radiographic, Angiographic, and Interventional applications.
| Date | Mar 16, 2012 (initiated Dec 26, 2011) |
| Status | Terminated |
| Reason | 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 | No Marketing Application |
| Action | 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. |
| Quantity | 2 units |
| Distribution | USA Nationwide Distributed in Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983069 | PHILIPS DUO DIAGNOST Philips Medical Systems North America, Inc., Nov 2, 1998 |