Date Initiated by Firm | December 15, 2017 |
Date Posted | February 03, 2018 |
Recall Status1 |
Terminated 3 on April 10, 2020 |
Recall Number | Z-0513-2018 |
Recall Event ID |
79088 |
510(K)Number | K041218 |
Product Classification |
System, tomography, computed, emission - Product Code KPS
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Product | Precedence 6 Model # 882351
Product Usage:
Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals. |
Code Information |
Precedence 6 Model # 882351 Serial Numbers : KP06080001 KP06090002 3000027 3000028 747866A0 KP06020006 30007020021 KP06080010 3000030 KP06090012 KP06100013 KP06110015 30007030020 30007010017 30007030021 30007060024 30007070025 30007050023 30007050022 3000029 3000036 3000002 3000040 3000031 3000032 3000033 3000038 3000035 3000034 3000039 H3000037 3000042 3000041 3000043 3000044 3000046 3000045 30007030016 3000003 3000037 6111502 KP06070007 KP06080008 |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
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For Additional Information Contact | Holly Wright Lee 440-483-2950 |
Manufacturer Reason for Recall | During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Philips sent an Urgent Field Safety Notice letter dated December 15, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local Philips representative. |
Quantity in Commerce | 1387 in total |
Distribution | Worldwide Distribution - US Nationwide |
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
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