FDA Device recall Z-2346-2016
MX 16-slice whole body computed tomography X-ray system
- FDA Device
- Class II
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class II recall of MX 16-slice whole body computed tomography X-ray system by Philips Medical Systems Cleveland, citing 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 f….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2346-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-20 |
| Published | 2016-08-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | AL, AR, CA, FL, GA, IL, IN, MS, NC, ND, NJ, NV, NY, OH, PA, SC, TN, VA |
Product
MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool.
Reason
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
Identifiers
| code_info | Model No. 728131, S/N: EP16E090001 EP16E090002 EP16E090003 EP16E090004 EP16E090006 EP16E090007 EP16E090008 EP16E0900…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 EP |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2346-2016%22
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