• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall BrightView Gamma Camera Radius Drive

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


New Search Back to Search Results
 Class 2 Recall
BrightView Gamma Camera Radius Drive
see related information
Date Posted September 16, 2009
Recall Status1 Terminated on April 12, 2010
Recall Number Z-1892-2009
Recall Event ID 52704
Premarket Notification
510(K) Number
K062298 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product BrightView Gamma Camera Radius Drive Assembly, manufactured by Philips Medical Systems (Cleveland) Inc., Cleveland, OH, 3/8" tilt, model number 4535604 34811, 3/4"tilt, model number 4535674 34801, and 3/8" fixed, model number 4535604 34781, all catalog number 882480 Medical device-- intended to produce images depicting anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.
Code Information All units: 3/8" tilt, model number 4535604 34811, 3/4"tilt, model number 4535674 34801, and 3/8" fixed, model number 4535604 34781, all catalog number 882480
Recalling Firm/
Manufacturer
Phillips Nuclear Medicine
540 Alder Dr Bldg 4
Milpitas, California 95035-7443
Manufacturer Reason
for Recall
Unexpected movement-- if the drive assembly is severely compromised, the detector may slide to its hardware limit.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Firm initiated its recall notification on July 6, 2009 issuing a field safety notice to its consignees via FedEx and internationally through its personnel. Responses will be tracked for effectiveness. Questions may be directed to Philips Customer Care Center at 1.800.722.9377.
Quantity in Commerce 288 units
Distribution Worldwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = ADAC LABORATORIES
-
-