FDA Device

TumorLoc software for the Brilliance Big Bore (BB) and the CT Extended Brilliance Workstation (EBW), Model #4550 116 02431 (TumorLoc). The BB is a CT X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

Hazard

A software error in the TumorLoc software was discovered upon receipt of a customer complaint. There is the potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series ID.

What You Should Do

Remedy

Philips Medical issued an 'URGENT -Medical Device Correction' document dated January 28, 2009. This notification informs consignees of the TumorLoc imaging issue, the inherent hazards involved should this problem occur, the circumstances under which this problem may occur and corrective actions which the user/customer should perform in the event that this problem is encountered. It also informs that user/customer that Philips will have their Service Engineers contact the customers within 6 months to install a TumorLoc upgrade. For further questions, contact the Phillips Customer Care Center at 1-800-722-9377.

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Products

TumorLoc software for the Brilliance Big Bore (BB) and the CT Extended Brilliance Workstation (EBW), Model #4550 116 02431 (TumorLoc). The BB is a CT X-ray system intended to produce cross-sectional
Brand
Philips Medical Systems (Cleveland) Inc
UPC
Lot Numbers: 7001-7354 for BB; and 8222, 8270, 8709, 8838, 8841, 8862, 8986, 9014, 9019, 9127, 9166, 10331, 10348, 10364, 10402, 10705, 10827, 11002, 11047, 11055, 11096, 11362, 11588, and 11597, for EBW.

Units Affected

356 units

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