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U.S. Department of Health and Human Services

Class 2 Device Recall INGENUITY DIGITAL PET/CT

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 Class 2 Device Recall INGENUITY DIGITAL PET/CTsee related information
Date Initiated by FirmJune 24, 2019
Date PostedAugust 06, 2019
Recall Status1 Terminated 3 on October 06, 2022
Recall NumberZ-2194-2019
Recall Event ID 83365
510(K)NumberK123599 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductVereos PET/CT Model # 882446, computed tomography x-ray system
Code Information System Serial Number 900004 through 900076 
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information ContactMs. Holly Wright Lee
440-483-5777
Manufacturer Reason
for Recall
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
FDA Determined
Cause 2
Other
ActionPhilips Healthcare issued a Field Safety Notification (FSN)72800720/88200522 1. Identify affected product 2. There are 3 scenarios users may experience which result in identical images that are incorrectly labeled as phase tolerance images. A. When performing a Step and Shoot acquisition with phase tolerance selected, images may be reconstructed identically (a single phase), but are labeled as different phases. This occurs when Start Final Recon is selected prior to display of the ECG wave at the top of the acquisition window. B. When performing a Step and Shoot acquisition with phase tolerance selected, images may be reconstructed identically (a single phase), but are labeled as different phases. This occurs if ECG leads become disconnected mid-acquisition or when the acquisition is halted prematurely due to an application crash. C. By system design, in certain instances when a patient exhibits an arrhythmia or varying heart rate during a Step and Shoot acquisition, images from the acquisition following the heart rate variation, may be labeled in the incorrect phase 4. Determine whether you have a potentially affected system, then determine your AFFECTED PRODUCTS software version. To identify the software version of your product: Click the Help button, Select About and the software version is then displayed, Software versions 4.x, 3.x, and 2.x are potentially affected. 5. Take the Action listed in the field safety notice. Please retain a copy with the equipment Instruction for use. If you need any further information or support concerning this issue, please contact your local Philips representative: North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377 and follow the prompts).
Quantity in Commerce26
DistributionWorldwide distribution. US nationwide including Puerto Rico, Canada, Mexico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Cote D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gibraltar, Greece, Greenland, Guyana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malawi, Malaysia, Maldives, Mali, Malta, Martinique, Mauritius, Monaco, Mongolia, Morocco, Mozambique, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, State of Palestine, Panama, Peru, Philippines, Poland, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, and Yemen
Total Product Life CycleTPLC Device Report

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.
510(K) Database510(K)s with Product Code = JAK
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