Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MX 16-slice SKD whole body computed tomography X-ray system. Imaging Recalled by Philips Medical Systems (Cleveland) Inc Due to The following issues have been found in MX...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Medical Systems (Cleveland) Inc directly.
Affected Products
MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
Quantity: 80 units
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed to 18 states: AL, AR, CA, FL, GA, IL, IN, MS, NV, NJ, NY, NC, ND, OH, PA, SC, TN, VA
About Philips Medical Systems (Cleveland) Inc
Philips Medical Systems (Cleveland) Inc has 313 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report