Date Initiated by Firm | April 13, 2012 |
Date Posted | May 22, 2012 |
Recall Status1 |
Terminated 3 on August 05, 2013 |
Recall Number | Z-1646-2012 |
Recall Event ID |
61809 |
510(K)Number | K103483 |
Product Classification |
Tomographic imager combining emission computed tomography with nuclear magnetic resonance - Product Code OUO
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Product | Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380.
The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). The system does not expose the patient to any ionizing radiation. The MRI Subsystem produces cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structures of the whole body. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient 's body (specific pharmaceuticals are used for whole body, brain, and other organ imaging). The PET and MRI portion of the system can be used either as an integrated system or as a stand-alone MRI or PET system. The MRI subsystem provides data suitable for use in attenuation correction of the PET acquired data. |
Code Information |
Serial Numbers 11004-11014 are subject to recall/software correction. |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Road Cleveland OH 44143-2131
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For Additional Information Contact | Joseph Vinhais 440-483-7000 |
Manufacturer Reason for Recall | Software errors. A number of non-conformances were identified and corrected by Philips Medical for their Ingenuity TF PET/MRI Systems running software version 3.7.1. The firm states that these non-conformances stemmed from software and/or documentation errors, and that software corrections are being performed in order to 'improve the overall quality and functionality of the Ingenuity TF CT/MRI S |
FDA Determined Cause 2 | Software design |
Action | The firm, Philips Medical, sent an 'URGENT - Medical Device Correction' notification letter dated April 13, 2012 to all affected customers via Certified mail. The letter informs the customers of the firm's upcoming software update. It tells the customers that the software for the Ingenuity TF PET/MR system unit will be upgraded from version 3.7.1 to version 3.7.2 and that the update/upgrade will provide a number of improvements to the overall quality and functionality of the Ingenuity TF PET/MR System. The notification document states that Philips will be installing the system update to version 3.7.2 software through a Field Change Order. This will be implemented free-of-charge and will include complementary PET/MR application training.
For further information, call toll-free telephone number which they can call 1-800-722-9377 and follow the menu options to reach a Customer Solutions Engineer. |
Quantity in Commerce | 8units (2 units in U.S. & 6 units in other countries) |
Distribution | Worldwide distribution: USA (nationwide) including states of: OH and NY; and countries of: China, Finland, Germany, South Korea, Spain, and 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
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