Brilliance Big Bore - Model #728243, and - Model #728244, CT Scanning System is subject to recall/correction Product Usa

FDA device recall Z-1692-2012 · posted 2012-05-30 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

Component defect. Following their receipt of a customer complaint, Philips Medical determined that the metal blocks which support the scissor slide rails underneath the scanning table (couch) of several of the firm's CT scanning systems were not manufactured to specification and may crack.

Action taken

Philips issued an 'URGENT Medical Device Correction' letter dated March 27, 2012 to all affected customers. The letter identified the affected products, problem, hazard involved, how to identify affected products, and actions to be taken by customer/user. The letter informed customers that Philips intends to dispatching service personnel to each customer site in order to correct this issue. In the meantime, the letter recommend customer to contact their Philips representative if they hear unusual noises when moving the couch vertically, or if there is unintended vertical motion of the couch. For questions 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

Nonconforming Material/Component

Status

Terminated

Product code

JAK

Quantity affected

12 system units were distributed in the U.S.

Distribution

Worldwide Distribution - U.S. (Nationwide) including the states of: CA, FL,, HI, IA, IN, KY, LA, MA,, MI, MO, MS. NM, NV, OH, PA, PA, SC, TN, TX, WA, and Puerto Rico

Date initiated

2012-03-26

Date posted

2012-05-30

Date terminated

2013-02-22

Location

Cleveland, OH

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