| Class 2 Device Recall MX 16slice SKD whole body computed tomography Xray system | |
Date Initiated by Firm | April 20, 2016 |
Create Date | August 05, 2016 |
Recall Status1 |
Terminated 3 on July 02, 2018 |
Recall Number | Z-2347-2016 |
Recall Event ID |
74402 |
510(K)Number | K091195 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool. |
Code Information |
Model No. 728132; S/N: EP16ER100003, EP16ER100004, EP16ER100005, EP16ER100007, EP16ER100008, EP16ER110003, EP16ER110004, EP16ER110005, EP16ER110006, EP16ER110007, EP16ER110008, EP16ER110009, EP16ER110010, EP16ER110011, EP16ER110012, EP16ER110013, EP16ER110014, EP16ER110015, EP16ER110016, EP16ER110017, EP16ER110018, EP16ER110019, EP16ER110020, EP16ER110021, EP16ER110022, EP16ER110023, EP16ER110024, EP16ER120001, EP16ER120002, EP16ER120003, EP16ER120004, EP16ER120005, EP16ER120006, EP16ER120007, EP16ER120008, EP16ER120010, EP16ER120012, EP16ER120015, EP16ER120016, EP16ER120017, EP16ER120018, EP16ER130001, EP16ER130002, EP16ER130005, EP16ER130006, EP16ER130007, EP16ER130008, EP16ER130009, EP16ER130010, EP16ER130011, EP16ER130012, EP16ER130013, EP16ER130014, EP16ER130015, EP16ER130016, EP16ER130018, EP16ER130025, EP16ER130026, EP16ER130029, EP16ER130033, EP16ER130034, EP16EB150009 & EP16EB150014. Model No.728135; S/N: EP16E120009, EP16E120011, EP16E120013, EP16ER130003, EP16ER130004, EP16ER130017, EP16ER130019, EP16ER130020, EP16ER130021, EP16ER130022, EP16ER130023, EP16ER130024, EP16ER130027, EP16ER130028, EP16ER130030, EP16ER130031 & EP16ER130032. |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
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For Additional Information Contact | Mrs. Holly Wright-Lee 440-483-2997 |
Manufacturer Reason for Recall | The following issues have been found in MX 16-slice systems with software version 1.1.4.21426:
1. During the filming operation on MX16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patients images before pasting, a previous patients images may be present in the clipboard and be copied onto the film of the current patient.
2. During the Bolus Tracking scan, if the Auto Voice in Tracker scan is enabled, the Tracker scan will be aborted unexpectedly and the diagnostic scan after the tracker scan needs to be manually started.
3. If the scan protocol with SAS (Spiral Auto Start) function is selected to plan the scan, the SAS option may not be displayed on the Contrast tab of the scan protocol parameter area or the SAS option is displayed but not enabled as pre-configured in the protocol. This issue only occurs on the first helical scan after system startup that applies SAS function |
FDA Determined Cause 2 | Software design |
Action | On April 20, 2016 the firm sent Field Safety Notices to their customers. Philips will release a Field Change Order to upgrade the software free of charge.
A Philips Field Engineer will contact their customers to schedule this correction. |
Quantity in Commerce | 80 units |
Distribution | Products were sold in the following states: AL, AR, CA, FL, GA, IL, IN, MS, NC, ND, NJ, NV, NY, OH, PA, SC, TN & VA.
Products were also shipped to the following countries: Albania, ALGERIA, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Burundi, Cape Verde, Chile, China, Colombia, Congo, Democratic, Costa Rica, Cyprus, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hungary, India, INDONESIA, Ireland, Italy, Japan, Jordan, Latvia, Lebanon, Libyan Arab Jamahiri, Lithuania, Malawi, Mali, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, Nigeria, Oman, Palestine, Paraguay, Philippines, Poland, Romania, Russia, Senegal, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, United Kingdom, Venezuela, Viet Nam & Zambia. |
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 = JAK
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