Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2347-2016 — MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.

U.S. FDA — Device Enforcement · United States · 2016-04-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2347-2016
Date of alert
2016-04-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Medical Systems (Cleveland) Inc
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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