FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1220-2012
- Recalling firm
- Philips Healthcare Inc.
- 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.
- Status
- Terminated
- Initiated
- 2011-12-26
- Posted
- 2012-03-16
- Terminated
- 2013-11-01
- 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
- Lot, serial or model codes
- S/N: 07110582 and 09100826
- 510(k) numbers
- ["K983069"]
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28