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Class 2 Device Recall Ingenuity TF PET/MR |
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Date Initiated by Firm |
July 23, 2015 |
Date Posted |
August 31, 2015 |
Recall Status1 |
Terminated 3 on June 26, 2018 |
Recall Number |
Z-2491-2015 |
Recall Event ID |
71882 |
510(K)Number |
K103483
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Product Classification |
Tomographic imager combining emission computed tomography with nuclear magnetic resonance - Product Code OUO
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Product |
Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems |
Code Information |
M/N 882380; S/N: 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014 & 24061. |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
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For Additional Information Contact |
Mr. Yuchol Kim 440-483-2997
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Manufacturer Reason for Recall |
Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun, even though no actual database lockup issue has been reported in the field-installed Ingenuity TF PET/MR systems.
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FDA Determined Cause 2 |
Software design |
Action |
On July 23, 2015 the firm sent Field Safety Notices to their customers. |
Quantity in Commerce |
11 |
Distribution |
Product was shipped to the following states: NY, OH & TX.
Product was also shipped to the following countries: Finland, Germany, Hong Kong, Japan, Netherlands, South Korea, Spain & Switzerland. |
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 = OUO and Original Applicant = PHILIPS HEALTHCARE (CLEVELAND)
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