Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance i

FDA device recall Z-0832-2014 · posted 2014-01-27 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

Patient images exhibited ring artifacts.

Action taken

The firm, Philips Healthcare, sent an "URGENT - Medical Device Correction" letter dated December 9, 2013 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following to avoid the occurrence of these specific ring artifacts: 1. Disable Automatic Scan Time for all Exam Cards 2. Leave Automatic Scan Time on during planning and prior to clicking Go to initiate the scan, click the acquisition series of the scan and disable Automatic Scan Time, then proceed with the scan. 3. Disable Edit Before Final Recon (Reconstruction) for all Exam Cards If a ring artifact is present, clinical judgment should be used by the customer/user to determine if the images acquired in the dataset contain enough information to make a diagnosis. Philips will be releasing a Field Change Order (FCO) to correct the issue with software version release 4.1.1.19261. In addition, 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 Customer Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID or follow the prompts).

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

7 units

Distribution

Worldwide Distribution: US (nationwide) including states of: FL, IN, NY, OR and PA; and internationally to: Australia and Israel.

Date initiated

2013-12-09

Date posted

2014-01-27

Date terminated

2014-05-29

Location

Cleveland, OH

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