Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall CombiDiagnost R90

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall CombiDiagnost R90see related information
Date Initiated by FirmSeptember 22, 2021
Create DateNovember 24, 2021
Recall Status1 Open3, Classified
Recall NumberZ-0241-2022
Recall Event ID 89023
510(K)NumberK203087 
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
ProductCombiDiagnost R90 is multi-functional general R/F systems.
Code Information CombiDiagnost R90
Recalling Firm/
Manufacturer		 Philips Healthcare
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information ContactDusty Leppert
978-228-0190
Manufacturer Reason
for Recall		The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionPhilips sent an Electronic Product Radiation Correction letter to inform customers. The letter identified the affected product, problem and actions to be taken. Customers were informed Philips Field Service Engineer will visit their site to check for the required labels and if they are missing, will resolve the issue by applying the required labels. Customers were instructed to complete and return the attached acknowledgment form to Philips DXR via email to DIFCO@philips.com. For questions contact Customer Care Solutions Center 1-800-722-9377.
Quantity in Commerce281 in total
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 = JAA
-
-