Z-1220-2012

DuoDiagnost, model 707015, Universal RF system

Name: Z-1220-2012 DuoDiagnost, model 707015, Universal RF system
Creator: Philips Healthcare Inc.
Published: 2011-12-26
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-12-26 / Terminated / root cause: design

FDA source

Philips Healthcare Inc. began a recall of DuoDiagnost, model 707015, Universal RF system Product Usage: is a mult-functional diagnostic X-Ray system intended for Fluorosopic, Radiographic... on 2011-12-26. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1220-2012
Status: Terminated
Initiated: 2011-12-26
Posted: 2012-03-16
Terminated: 2013-11-01
Recalling firm: Philips North America LLC
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.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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.
Root cause tag: design
FDA 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 in commerce: 2 units
Distribution: USA Nationwide Distributed in Puerto Rico
Product codes and lots: S/N: 07110582 and 09100826

Product code JAA

K983069Class IIPhilips Duo DiagnostPhilips Medical Systems North America, Inc. / cleared 1998-11-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)