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Terminated

Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, System Code: 728255; MX8000 IDT 16, System Code: 728120 & MX8000 IDT 10, System Code: 728125 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.

FDA Recall Z-1338-2013 · Posted 2013-05-20

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2013-03-12
Date Terminated2015-06-30
Product Quantity515 units

Reason for Recall

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.

Firm Action

The firm, Philips Healthcare, sent an "Urgent - Medical Device Correction" letter dated March 15, 2013, to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to disregard unusually higher CTDIvol value for Type-3 DICOM tag 0018:9345 in the PACS system, if seen. The firm is implementing software update versions 4.2.2 or 2.2.2 to correct the issue. A Philips Field Service Engineer will contact you to schedule the software installation at your site. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customers Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID or follow the prompts).

Root Cause

Use error

Distribution Pattern

Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, VA, VT, WA, WI, WV and WY; countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Denmark, France, Germany, Gibraltar, India, Iraq, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Philippines, Poland, Portugal, Singapore, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012009MX8000 IDT CT SYSTEMMarconi Medical Systems, Inc. · 2001-09-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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