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 Philips DigitalDiagnost, DualDetector

  • 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 Philips DigitalDiagnost, DualDetector see related information
Date Initiated by Firm June 27, 2018
Date Posted August 17, 2018
Recall Status1 Terminated 3 on April 30, 2024
Recall Number Z-2865-2018
Recall Event ID 80577
510(K)Number K090625  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052
Code Information Serial Numbers:  363679 404164/SN0802462 378830/SN0802004 341693 358494 359442 396571/SN0802311 359449 346075 382021/SN0802313 374374 404298/SN0802474 402570/SN0802420 373501 373500 382272/SN0802113 368428 382012/SN0702520 376667 356957 392502/SN0802179 407423/SN0802638 359767 368619 358641 357697 381998/SN0702488 413829/SN0802631 358320 400364/SN0802522 404166/SN0802441 356981 390272/SN0802364 390273/SN0802366 412482/SN0802683 348997 396576/SN0802233 372848 373508 383084/SN0802127 
Recalling Firm/
Manufacturer		 Philips Medical Systems Gmbh, DMC
Development And Manufacturing Ctr.
Rontgenstr. 24
Hamburg Germany
For Additional Information Contact Philips Service Engineer
40-50782110
Manufacturer Reason
for Recall		 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
FDA Determined
Cause 2		 Device Design
Action On June 27, 2018, Philips Medical Systems issued URGENT FIELD SAFETY NOTICES, Medical Device Recall letters to customers. Customers were encouraged to always check the right position of the hook and ensure that the hook is locked according tot he IFU. Press hook down until it is locked. Make sure that the hook is in position. A Philips Service Engineer will contact impacted customers as soon as the Field Action Kit is ready to be implemented. Should you need to communicate with Philips in regards to this program, please reference FCO-71200185. If you need further information or support concerning this issue, please contact your local Philips representative.
Distribution US Nationwide; International to 66 countries
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MQB and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
-
-