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U.S. Department of Health and Human Services

Class 2 Device Recall DigitalDiagnost

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 Class 2 Device Recall DigitalDiagnostsee related information
Date Initiated by FirmMay 19, 2021
Date PostedJuly 12, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1326-2022
Recall Event ID 90490
510(K)NumberK210692 
Product Classification System, x-ray, stationary - Product Code KPR
ProductDigitalDiagnost 4 High Performance. radiography and fluoroscopy system
Code Information Model 712031 Serial Numbers -  10001009 10001111  18000123  19000181 20010235 10001039 17000264 18000263 19000297
Recalling Firm/
Manufacturer		 Philips Medical Systems DMC GmbH
Development And Manufacturing Ctr.
Rontgenstr. 24-26
Hamburg Germany
For Additional Information ContactDusty Leppert, CHP
978-228-0190
Manufacturer Reason
for Recall		Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionPhilips sent an Electronic Product Radiation Defect notification letter dated May 25, 2022 to affected customers. Philips will schedule an appointment with customers to install the software update. Philips will, without charge bring the product into compliance. Customers were instructed to complete and return the attached response form to Philips. For further information or support concerning this issue, please contact Philips Customer Care Solutions Center: 1-800-722-9377 and reference FCO71200223 for impacted DigitalDiagnost systems or FCO70600109 for impacted ProxiDiagnost systems.
Quantity in Commerce140 systems in total, (Updated 1/30/2023).
DistributionUS Nationwide Distribution
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KPR
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