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Recall Observatory FDA recall evidence

Device product

Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room to enhance workflow and make additional non-magnetic hospital beds unnecessary.

Z-1827-2014

May 15, 2014

Class II

Product summary

Firm
Philips Medical Systems, Inc.
Event
Event 68311
Status
Terminated
Classification
Class II
Quantity
5
Official record key
device-enforcement:Z-1827-2014

Official wording

Reason: Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.

Code information: Model Number: 9896 030 1929.1

Distribution pattern: Worldwide Distribution - US (nationwide), Canada, Mexico Australia, Austria, Germany, Belarus, Bulgaria, Brazil, China, Denmark, Estonia, Finland, France, Germany, Greece, Italy, Jordan, Korea, Republic of Korea, Netherlands, New Zealand, Norway, Oman, Pakistan, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.