Reported Jul 25, 2012 · Terminated
Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. The devices are…
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 Road · Cleveland, OH · 44143-2131
Is this the product you have?
- Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. The devices are Computed Tomography Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes
- Lot codes and dates
527 of 527 codes
Brilliance 64M/N #728231Serial #s101401014110142101431014410145101461014710148101491015010151101521015310154101551015610157101581015910160101611016210163101641016510166101671016810169101701017110172101731017410175101761017710178101791018010181101821018310184101851018610187101881018910190101911019210193101941019510196
- Amount recalled
- 524
Where it was sold
Why it was recalled
Philips Healthcare was notified that several of the sixteen bolts securing the brackets which support the carbon table top on various models of their Brilliant CT scanner have been found to be defective and the bolt heads may break off.
This product could cause temporary or reversible health problems — stop using it.
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