Vertical Brake Hubs of the Computed Tomography X-Ray Systems under the following Brands and Model #s: Brilliance 6, M/Ns

FDA device recall Z-1669-2011 · posted 2011-03-16 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

Philips Medical Systems has decided to recall the patient support vertical brake hub in all its Brilliance systems due to the collapse in the vertical direction. The short key connecting the vertical brake hub to the motor shaft can disengage due to the lack of thread locker on set screws.

Action taken

Philips Medical Systems (Cleveland) Inc sent Field Safety Notice to all affected customers on December 10, 2010. The Safety Notices identified the product, the problem, and the action to be taken by the customer. Customers were instructed to monitor their units and if the vertical brake hub malfunctioned to immediately contact the recalling firm. The letter also stated that a Field Service Engineer would visit to perform a brake hub rework on the units. For further information or support customers were to contact their 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 prompt(s). For questions regarding this recall call 440-483-7672.

Root cause

Other

Status

Terminated

Product code

KPS

Quantity affected

5700 units/vertical brake hubs

Distribution

Worldwide Distribution - USA including 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, NM, NV, NY, OH, OK, OR, PA, PR, RI,

Date initiated

2010-12-10

Date posted

2011-03-16

Date terminated

2013-08-21

Location

Cleveland, OH

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