Z-0612-2019Class II

Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System

Name: Z-0612-2019 Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Creator: Philips Medical Systems Gmbh, DMC
Published: 2018-11-07
License: https://open.fda.gov/license/

Philips Medical Systems DMC GmbH / initiated 2018-11-07 / Terminated / root cause: software

FDA source

Philips Medical Systems Gmbh, DMC began a recall of Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System on 2018-11-07. FDA classified it as Class II and gives the reason as "kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0612-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-07
Posted: 2019-02-12
Terminated: 2020-09-02
Recalling firm: Philips Medical Systems DMC GmbH
Product: Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0612-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0612-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-20	2019-02-12

Product code JAA

K163210Class IIPhilips CombiDiagnost R90Philips Medical Systems Dmc GmbH / cleared 2017-01-31

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)