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U.S. Department of Health and Human Services

Class 2 Device Recall BrightView Gamma Camera Radius Drive

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  Class 2 Device Recall BrightView Gamma Camera Radius Drive see related information
Date Initiated by Firm July 02, 2009
Date Posted September 16, 2009
Recall Status1 Terminated 3 on April 12, 2010
Recall Number Z-1892-2009
Recall Event ID 52704
510(K)Number K062298  
Product Classification Emission computed tomography system - 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 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
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 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) Database 510(K)s with Product Code = KPS and Original Applicant = ADAC LABORATORIES
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