Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, and 300005.

FDA device recall Z-0779-2012 · posted 2012-01-17 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

Software errors. A number of non-conformances were logged during in-house testing and external validation testing of Brilliance 64, Brilliance Big Bore, and Ingenuity CT systems, equipped with software version 3.5 Beta 2. The non-conformances are due to software errors identified in these device systems.

Action taken

Philips sent an "URGENT - Medical Device Correction" notification letters to all affected customers via Certified mail on October 19, 2011. The letter describes the referenced software issues; provides instructions to the customers as to what they can do in order to address these issues; and informs the customers of the firm's upcoming software field/correction. The letter states that a Philips representative will be contacting all affected customers to install the necessary software upgrade through a Field Change Order. This will be implemented free of charge. For information or support contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solution Center 1-800-722-9377, option 5.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JAK

Quantity affected

3 units

Distribution

Worldwide Distribution - Nationwide (USA) including the states of: IN, MI, MO, NY, OH, and OR and the countries of Germany, Israel and Netherlands.

Date initiated

2011-08-29

Date posted

2012-01-17

Date terminated

2013-02-22

Location

Cleveland, OH

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