Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Co

FDA device recall Z-1722-2014 · posted 2014-06-04 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

A customer reported that the table top had become free floating. A Field Service Engineer (FSE) confirmed that the service latch had become disengaged.

Action taken

Philips Healthcare sent an Urgent Medical Device Correction letter dated April 1, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed If they experience a horizontal, free-floating couch motion, to contact their Field Service Engineer immediately. Customers were instructed to retain a copy of this Field Safety Notice with the equipment Instructions for USER Use (IFU). Customers with questions or needing further information were instructed to contact their local Philips representataive or local Philips Healthcare office. For North America, contact the Customer Care Solutions Center at 1-800-722-9377, Option 5. For questions regarding this recall call 440-483-3032.

Root cause

Component design/selection

Status

Terminated

Product code

JAK

Quantity affected

6, 839 units

Distribution

Worldwide Distribution: US nationwide including PR and DC, Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bhutan, Bolivia, Bosnia, Bra

Date initiated

2014-04-01

Date posted

2014-06-04

Date terminated

2018-06-26

Location

Cleveland, OH

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