FDA Medical Device Recalls (openFDA)
Philips Medical Systems Gmbh, DMC: Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
- Recall number
- Z-0612-2019
- Recalling firm
- Philips Medical Systems Gmbh, DMC
- Product
- Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
- Status
- Terminated
- Initiated
- 2018-11-07
- Posted
- not on file
- Terminated
- 2020-09-02
- Reason
- kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
- Root cause
- Software design (manufacturing process)
- Action
- On November 7, 2018, Philips Medical Systems distributed an URGENT MEDICAL DEVICE RECALL" notices dated 10/16/2018 to customers. The following are Actions to Be Taken by the Customer: **If the kV/mA lockin not functioning as specified**: The operator can recognize the issue by observing the increasing mA value. In general the system can be used according to the Instruction for Use without restrictions. **If the Stitching with SkyPlate aborts after first image**: There are no actions to be taken by the user in these situations. The customer is notified at the end of the stitching run that the run failed. Customers can continue to use the device in accordance with this notice and the IfU. Philips will provide an upgrade of all CombiDiagnost R90 systems in the field to Rel.1.0.3 (Eleva package incl. improved clinical EPX database). A Philips Service Engineer will contact you when the Field Action Kit is available to be implemented. Should you need to communicate with Philips with regard to this program, please reference Field Change Order 70900042. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.
- Quantity
- 146
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AZ, CA, GA, IL, MN, MO, MT, NJ, OH, TX, UT & VA; and to countries of: Australia, Austria, Bangladesh, Belgium, Chile C¿te D'Ivoire, Czech Republic. Egypt, Ethiopia, France, Germany, Ghana, Iran, Italy, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Philippines, Portugal Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates and United Kingdom.
- Lot, serial or model codes
- All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2
- 510(k) numbers
- ["K163210"]
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 3003768251
- Firm city
- Hamburg
- Firm state
- not on file
- Firm country
- Germany
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