MX 16-slice SKD whole body computed tomography X-ray system — Class II medical device recall Z-2347-2016
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2016-08-17, distributed in AL, AR, CA, FL, GA, IL, IN, MS…. The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: 1. During the f
| Recall number | Z-2347-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2016-04-20 |
| Classified | 2016-08-05 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2018-07-02 |
| Distributed | AL, AR, CA, FL, GA, IL, IN, MS, NC, ND, NJ, NV, NY, OH, PA, SC, TN, VA |
| Countries outside the US | AR, AT, AU, BD, BE, BG, BR, CH, CL, CN, CO, CR, CY, DE, DO, DZ, EC, EG, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JO, JP, KR, LB, LK, LT, LV, MA, MX, NG, NL, NP, OM, PH, PL, PY, RO, RU, SK, TH, TN, TR, TW, VE, VN, ZA |
| Quantity | 80 units |
| Reason classes | software, unapproved product |
| Model numbers | 728132, 728135 |
Product
MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2347-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.