The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional

FDA device recall Z-2223-2012 · posted 2012-08-17 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

1. The current system design of software version 4.0.0xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for CT Brain Perfusion scanning, which previous versions did. However, the current version does have the Dose Check (NEMA XR-25) feature, which provides dose notifications and alerts, but it is possible for the user to disable Dose Check after ente

Action taken

Philips Healthcare sent an URGENT - Medical Device Correction letter date July 18, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Phillips will be installing a software update version 4.0.0xx516. A Philips Service Engineer will contact the customer for implementation of the software update on the affected systems free of charge. For further information or support concerning this issue, customers may contact their local Philips representatives or Philips Healthcare office. For North America and Canada, they may also contact the Customer Care Solutions Center (1-800-722-9377, option 5) For questions regarding this recall call 440-483-7000.

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

8

Distribution

Worldwide Distribution - USA including IN and OH, also, the countries of Australia, Belgium, China, Israel, and Sweden

Date initiated

2012-07-18

Date posted

2012-08-17

Date terminated

2013-02-22

Location

Cleveland, OH

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