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 Digital Diagnost

  • 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 Digital Diagnostsee related information
Date Initiated by FirmOctober 30, 2012
Date PostedMarch 01, 2013
Recall Status1 Terminated 3 on July 29, 2013
Recall NumberZ-0900-2013
Recall Event ID 63671
510(K)NumberK982795 
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
ProductPhilips Digital Diagnost Stationary radiographic system
Code Information All Digital Diagnost systems with Eleva software version 3.0.x
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information ContactBeth St. Germain
978-659-4519
Manufacturer Reason
for Recall		When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.
FDA Determined
Cause 2		Software design
ActionPhilips Healthcare issued an Urgent Field Safety Notice dated October 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to review the information contained in the Notice with all member of their staff who need to be aware of the contents. Also, customers were asked to retain a copy with the equipment Instruction for Use. For further information or questions customers were instructed to contact their local Phillips representative Technical Support Line at 1-800-722-9377. For questions regarding this recall call 978-659-4519.
Quantity in Commerce360
DistributionWorldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Canada, Chile, Czech republic, Estonia,France, Germany, Hungary, Inida, Ireland, Italy, Japan, Libyan Arab Jamahari, Mexico, Netherlands, New Zealand, Norway , Oman, Panama, Peru, Poland, Qatar, Reunion, Russia, Saudi Arabia, South Africa, South Korea,Spain, Sweden, Swizerland, Thailand, UAE, and the UK.
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 = MQB
-
-