Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Sl

FDA device recall Z-1338-2013 · posted 2013-05-20 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

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.

Action taken

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

Status

Terminated

Product code

JAK

Quantity affected

515 units

Distribution

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

Date initiated

2013-03-12

Date posted

2013-05-20

Date terminated

2015-06-30

Location

Cleveland, OH

Related 510(k) clearances