MX 16-slice whole body computed tomography X-ray system
Medical device recall Z-2346-2016. Published in FDA’s Enforcement Report on Aug 17, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 17, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 18 states named in where it went
- 899 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool.
899 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model No. 728131, S/N: EP16E090001 EP16E090002 EP16E090003 EP16E090004 EP16E090006 EP16E090007 EP16E090008 EP16E090009 EP16E090010 EP16E090011 EP16E090012 EP16E090013 EP16E090014 EP16E090015 EP16E100001 EP16E100002 EP16E100003 EP16E100004…
Every code shown here, 1,991 characters
Model No. 728131, S/N: EP16E090001 EP16E090002 EP16E090003 EP16E090004 EP16E090006 EP16E090007 EP16E090008 EP16E090009 EP16E090010 EP16E090011 EP16E090012 EP16E090013 EP16E090014 EP16E090015 EP16E100001 EP16E100002 EP16E100003 EP16E100004 EP16E100005 EP16E100006 EP16E100007 EP16E100008 EP16E100009 EP16E100010 EP16E100011 EP16E100012 EP16E100013 EP16E100014 EP16E100015 EP16E100016 EP16E100017 EP16E100018 EP16E100019 EP16E100020 EP16E100021 EP16E100022 EP16E100023 EP16E100024 EP16E100025 EP16E100026 EP16E100027 EP16E100028 EP16E100029 EP16E100030 EP16E100031 EP16E100032 EP16E100033 EP16E100034 EP16E100035 EP16E100036 EP16E100037 EP16E100038 EP16E100039 EP16E100041 EP16E100042 EP16E100043 EP16E100044 EP16E100045 EP16E100046 EP16E100047 EP16E100048 EP16E100049 EP16E100050 EP16E100051 EP16E100052 EP16E100053 EP16E100054 EP16E100055 EP16E100056 EP16E100057 EP16E100058 EP16E100059 EP16E100060 EP16E100061 EP16E100062 EP16E100063 EP16E100067 EP16E100069 EP16E100070 EP16E100071 EP16E100072 EP16E100073 EP16E100074 EP16E100075 EP16E100076 EP16E100077 EP16E100078 EP16E100079 EP16E100080 EP16E100081 EP16E100082 EP16E100083 EP16E100084 EP16E100085 EP16E100086 EP16E100087 EP16E100088 EP16E100089 EP16E100090 EP16E100091 EP16E100092 EP16E100093 EP16E100094 EP16E100095 EP16E100096 EP16E100097 EP16E100098 EP16E100099 EP16E100100 EP16E100101 EP16E100102 EP16E100103 EP16E100104 EP16E100105 EP16E100106 EP16E100107 EP16E100108 EP16E100109 EP16E100110 EP16E100111 EP16E100112 EP16E100113 EP16E110001 EP16E110002 EP16E110003 EP16E110004 EP16E110005 EP16E110006 EP16E110007 EP16E110008 EP16E110009 EP16E110010 EP16E110011 EP16E110012 EP16E110013 EP16E110014 EP16E110015 EP16E110016 EP16E110017 EP16E110018 EP16E110019 EP16E110020 EP16E110021 EP16E110022 EP16E110023 EP16E110024 EP16E110025 EP16E110026 EP16E110027 EP16E110028 EP16E110029 EP16E110030 EP16E110031 EP16E110032 EP16E110033 EP16E110034 EP16E110035 EP16E110036 EP16E110037 EP16E110038 EP16E110039 EP16E110040 EP16E110041 EP16E110042…
FDA’s list runs to 10,762 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
18 states and territories.
Every one of them
- Alabama
- Arkansas
- California
- Florida
- Georgia
- Illinois
- Indiana
- Mississippi
- North Carolina
- North Dakota
- New Jersey
- Nevada
- New York
- Ohio
- Pennsylvania
- South Carolina
- Tennessee
- Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 20, 2016.
- FDA classified it on Aug 5, 2016.
- FDA’s Enforcement Report published it on Aug 17, 2016.
- FDA terminated it on Jul 2, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Medical Systems (Cleveland) Inc, of Cleveland, OH.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 10,762 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.