Reported May 29, 2013 · Terminated
Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT…
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 16-Slice Water
- System Code
728245Brilliance CT 10-Slice Water
- System Code
728250Brilliance CT 6-Slice Water
- System Code
728255MX8000 IDT 16
- System Code728120 & MX8000 IDT 10
- System Code728125 Computed Tomography X-ray systems. Distributed by Philips Medical Systems (Cleveland), Inc., 595 Miner Road, Cleveland, OH 44143 Computed Tomography X-ray systems 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
- Lot codes and dates
511 of 511 codes
System Code #728255Serial #: 97029703970497059706970797099710971397149717971897199721972297239724972597279730973197329733973497359738973997409741974297439746974797499752975397569758975997609761976297659766976897699770977297749778978097819783978497869787979097919792
- Amount recalled
- 515 units
Where it was sold
Why it was recalled
Philips Healthcare received a report from the field stating when they viewed the CTDIVol information from the PACS system, the calculations were too high. Instead of storing the CTDIVol value for each slice in the DICOM tag, the system took the sum of all CTDIVol values from all the images in the dataset and stored this value in the DICOM tag, resulting in incorrect information.
This product could cause temporary or reversible health problems — stop using it.
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