Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography

FDA device recall Z-0945-2013 · posted 2013-03-13 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

Philips Healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. Philips has determined the cause was a malfunction of the vertical brake.

Action taken

Philips Healthcare sent a "Urgent Medical Device Correction" letter dated December 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were informed Philips received reports from the field stating that the screws holding the vertical brake together failed. A Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. If you need any further information please contact your local Philips representative or local Philips Healthcare office. For North America and Canada Contact the Customer Care Solutions Center at ( 1-800-722-9377, option 5: Enter Site ID or follow the prompts.

Root cause

Component design/selection

Status

Terminated

Product code

JAK

Quantity affected

4797 Units

Distribution

Worldwide Distribution - Nationwide Distribution including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,

Date initiated

2012-12-20

Date posted

2013-03-13

Date terminated

2014-04-17

Location

Cleveland, OH

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