FDA Device recall Z-2347-2016
MX 16-slice SKD 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 SKD 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-2347-2016 |
| 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 SKD 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. 728132; S/N: EP16ER100003, EP16ER100004, EP16ER100005, EP16ER100007, EP16ER100008, EP16ER110003, EP16ER1100…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, EP16ER13000 |
|---|
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-2347-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.