Company: Philips Medical Systems, Inc.
Date of Enforcement Report 8/17/2016
Class lI:
PRODUCT
MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
Recall Number Z-2347-2016
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 patient s images before pasting, a previous patient s 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.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Cleveland, OH on 4/20/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
80 Units
DISTRIBUTION
Nationwide and Internationally
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