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U.S. Department of Health and Human Services

Class 2 Device Recall CombiDiagnost R90

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 Class 2 Device Recall CombiDiagnost R90see related information
Date Initiated by FirmNovember 07, 2018
Create DateFebruary 12, 2019
Recall Status1 Terminated 3 on September 02, 2020
Recall NumberZ-0612-2019
Recall Event ID 81706
510(K)NumberK163210 
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
ProductStationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Code Information All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2 
Recalling Firm/
Manufacturer		 Philips Medical Systems Gmbh, DMC
Development And Manufacturing Ctr.
Rontgenstr. 24
Hamburg Germany
For Additional Information ContactEste Kinde
678-2960248
Manufacturer Reason
for Recall		kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
FDA Determined
Cause 2		Software design (manufacturing process)
ActionOn 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 Commerce146
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAA
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