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U.S. Department of Health and Human Services

Class 2 Device Recall Gemini 16, GS, GXL, Precedence.

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  Class 2 Device Recall Gemini 16, GS, GXL, Precedence. see related information
Date Initiated by Firm November 06, 2006
Date Posting Updated September 26, 2007
Recall Status1 Terminated 3 on October 05, 2010
Recall Number Z-0013-2007
Recall Event ID 37567
510(K)Number K042935  K041955  
Product Classification PET/CT computed tomography system - Product Code KPS
Product Nuclear medicine systems:
Gemini 16, Model 4535 679 28961.
Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691.
Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A.
PET/CT Computed tomography systems.
Code Information Serial #s: , 4034-4100, 4102, 4103, 1041
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information Contact George X. Kambic
440-483-2557
Manufacturer Reason
for Recall
A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator.
FDA Determined
Cause 2
Other
Action The customers were sent Public Safety Notification November 3, 2006, indicating there was a problem with the software. However, since their unit was recently upgraded the problem did not impact their unit.
Quantity in Commerce 70
Distribution Worldwide, including USA, Australia, Canada, China, England, Finland, France, Germany, Ireland, Israel, Italy, Japan, Jordan, Korea, Netherlands, Poland, Puerto Rico, Spain, and Taiwan.
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 = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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