Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MX 16slice SKD whole body computed tomography Xray system

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall MX 16slice SKD whole body computed tomography Xray system see related information
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
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
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
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) Database 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
-
-