MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
Published August 17, 2016 · Recall initiated: April 20, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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