Reported Jul 3, 2013 · Terminated
Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray…
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?
- Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
- Lot codes and dates
- The following
- codes are affected by this recall
System Code #728231Serial #: 965491003951309515795504 System Code #728326Serial #: 3200030000330000430000530001030001130001230001330001430001530001830002730004130005330005430005930006630007030007130007330007430077300078300079300080300082300084300086300091300092300095300101300102300112300119300127300128300129300131300132310064320030 System Code #728321Serial #: 310096310070 System Code #728323Serial #: 320033
- Amount recalled
- 50 units
Where it was sold
Why it was recalled
If the operator selects a patient name from the worklist using the mouse and then selects a different patient name using the keyboard (arrow keys then press enter) the patient name that populates the exam information page is the patient name selected with the mouse. Also, it is possible to begin a normal clinical scan while the anti-virus scan is running. However, if the user is running a bol
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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