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 MultiDiagnost Eleva

  • 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 MultiDiagnost Eleva see related information
Date Initiated by Firm June 08, 2004
Date Posted August 04, 2004
Recall Status1 Terminated 3 on February 09, 2006
Recall Number Z-1307-04
Recall Event ID 29470
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product MultiDiagnost Eleva
Part Numbers: 9896 001 41501 and 9896 001 41502
Code Information 505039, 104530, 506247, 102666, 104136, 104838, 506155, 105194.
Recalling Firm/
Manufacturer		 Philips Medical Systems Sales & Service Region No. America
22100 Bothell Everett Hwy
Bothell WA 98021
For Additional Information Contact Sarah Baxter
425-487-7665
Manufacturer Reason
for Recall		 When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination.
FDA Determined
Cause 2		 Other
Action The firm mailed letters via certified mail to their affected customers beginning on June 8, 2004. The letters instruct their customers to modify the default display on the ViewForum to exam/series date and time until a service representative can install the upgraded software R3.2.
Quantity in Commerce 8
Distribution Philips Medical Systems North American Company distributes product to medical facilities nationwide.
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.
-
-