Reported Aug 17, 2016 · Terminated
MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
Philips Medical Systems (Cleveland) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
- Lot codes and dates
- Model No. 728132
- S/N
62 of 62 codes
EP16ER100003EP16ER100004EP16ER100005EP16ER100007EP16ER100008EP16ER110003EP16ER110004EP16ER110005EP16ER110006EP16ER110007EP16ER110008EP16ER110009EP16ER110010EP16ER110011EP16ER110012EP16ER110013EP16ER110014EP16ER110015EP16ER110016EP16ER110017EP16ER110018EP16ER110019EP16ER110020EP16ER110021EP16ER110022EP16ER110023EP16ER110024EP16ER120001EP16ER120002EP16ER120003EP16ER120004EP16ER120005EP16ER120006EP16ER120007EP16ER120008EP16ER120010EP16ER120012EP16ER120015EP16ER120016EP16ER120017EP16ER120018EP16ER130001EP16ER130002EP16ER130005EP16ER130006EP16ER130007EP16ER130008EP16ER130009EP16ER130010EP16ER130011EP16ER130012EP16ER130013EP16ER130014EP16ER130015EP16ER130016EP16ER130018EP16ER130025EP16ER130026EP16ER130029EP16ER130033
- S/N
EP16E120009EP16E120011EP16E120013EP16ER130003EP16ER130004EP16ER130017EP16ER130019EP16ER130020EP16ER130021EP16ER130022EP16ER130023EP16ER130024EP16ER130027EP16ER130028EP16ER130030EP16ER130031 & EP16ER130032
- Amount recalled
- 80 units
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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