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

  • 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 Recallsee related information
Date Initiated by FirmFebruary 13, 2002
Date PostedSeptember 12, 2003
Recall Status1 Terminated 3 on April 11, 2005
Recall NumberZ-1223-03
Recall Event ID 26547
510(K)NumberK983447 
Product Classification System, Image Processing, Radiological - Product Code LLZ
ProductEasy Access PACS System with software Release 5, 6.2, or 7.2
Code Information To be provided
Recalling Firm/
Manufacturer		 Philips Medical Systems
22100 Bothell Everett Highway
Bothell WA 98041
For Additional Information Contact
425-487-7000
Manufacturer Reason
for Recall		Potential display of an incorrect body part description on patient images.
FDA Determined
Cause 2		Other
ActionOn 2/13/02 the firm issued a letter to their consignees. The letter provided a remedy to the situtaion.
Quantity in Commerce46 units
DistributionThe firm distributed units to 46 hospitals and medical centers located throughout the U.S.
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 = LLZ
-
-