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 BrightView Gamma Camera Radius Drive

  • 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 BrightView Gamma Camera Radius Drivesee related information
Date Initiated by FirmJuly 02, 2009
Date PostedSeptember 16, 2009
Recall Status1 Terminated 3 on April 12, 2010
Recall NumberZ-1892-2009
Recall Event ID 52704
510(K)NumberK062298 
Product Classification Emission computed tomography system - Product Code KPS
ProductBrightView 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
FEI Number 1525965
Recalling Firm/
Manufacturer		 Phillips Nuclear Medicine
540 Alder Dr Bldg 4
Milpitas CA 95035-7443
For Additional Information Contact
408-321-9100
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		Process control
ActionFirm 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 Commerce288 units
DistributionWorldwide
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 = KPS
-
-