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Class 2 Device Recall Gemini 16, GS, GXL, Precedence. |
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Date Initiated by Firm |
November 06, 2006 |
Date Posted |
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
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Product Classification |
PET/CT computed tomography system - Product Code KPS
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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
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For Additional Information Contact |
George X. Kambic 440-483-2557
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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