| Class 2 Device Recall Gemini TF 16 PET/CT; Gemini RF 64 PET/CT; Gemini TF Big Bore | |
Date Initiated by Firm | June 18, 2014 |
Date Posted | July 10, 2014 |
Recall Status1 |
Terminated 3 on September 16, 2015 |
Recall Number | Z-2037-2014 |
Recall Event ID |
68643 |
510(K)Number | K052640 K081135 |
Product Classification |
System, tomography, computed, emission - Product Code KPS
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Product | GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. |
Code Information |
GEMINI TF PET/CT16: 882470 7019,7039,7099,7588,7593,7598,7599,7600,7604,7605,7596M GEMINI TF PET/CT 64: 882471 7027,7044,7146,7153,7178,7182,7188,7578,7579,7585,7587,7589,7592,7594,7595,7602, 7603, 7606 GEMINI TF Big Bore: 882476 9019,9227,9232,9233 |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
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For Additional Information Contact | Kumudini j. Carter 440-483-7600 |
Manufacturer Reason for Recall | When beginning a procedure to start the gantry and CT Host, a Close Estop message may appear to the operator, but disappears before action can be taken. If this occurs it results in an inability to close E-Stop and the system is not operational for clinical use. This problem occurs randomly. |
FDA Determined Cause 2 | Software design |
Action | Philips Healthcare is informing the consignee of this issue through a Field Safety Notice (FSN) 88200487-488. The US consignees will receive this notice via certified mail and Philips Key Market representatives will distribute the FSN internationally. Additionally, a Field Service Engineer will contact each site to schedule a time to install the software update. |
Quantity in Commerce | 33 |
Distribution | Distributed in the states of CA, CO, IL, OK, OR and WI. |
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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