RegWardenFDA facility compliance records
Recall

Class II — Philips Medical Systems (Cleveland) Inc

Recalling firmPhilips Medical Systems International BV
Registered facilityView this company's 54 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonA customer reported that the table top had become free floating. A Field Service Engineer (FSE) confirmed that the service latch had become disengaged.
ProductPhilips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)
Quantity6, 839 units
DistributionWorldwide Distribution: US nationwide including PR and DC, Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bhutan, Bolivia, Bosnia, Brazil, Brunei Darussalam, Bulgaria, Canada, Cambodia, Cape Verde, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dubai, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, …
Initiated2014-04-01
Classified2014-06-04
Terminated2018-06-26
Recall numberZ-1722-2014
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Philips Medical Systems (Cleveland) Inc (Z-1722-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68245/

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