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Recall Observatory FDA recall evidence

Device product

Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System.

Z-2867-2016

September 14, 2014

Class II

Product summary

Firm
Invivo Corporation
Event
Event 74296
Status
Terminated
Classification
Class II
Quantity
639 units
Official record key
device-enforcement:Z-2867-2016

Official wording

Reason: Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notification was sent August 22, 2014.

Code information: Serial numbers US23200121, US23200122, US23200123, US23200124, US23200125, US23200126, US23200127, US23200128, US23200129, US23200130, US23200131, US23200132, US23200133, US23200134, US23200135, US23200136, US23200137, US23200138, US23200139, US23200140, US23200141, US23200142, US23200143, US23200144, US23200145, US23200146, US23200147, US23200148, US23200149, US23200150, US23200151, US23200152, US23200153, US23200154, US23200155, US23200156, US23200157, US23200158, US23200159, US23200160, US23200161, US23200162, US23200163, US23200164, US23200165, US23200166, US23200167, US23200168, US23200169, US23200170, US23200172, US23200173, US23200176, US23200177, US23200178, US23200179, US23200180, US23200181, US23200182, US23200183, US23200184, US23200188, US23200189, US23200190, US23200191, US23200192, US23200193, US23200194, US23200195, US23200196, US23200197, US23200198, US23200199, US23200200, US23200201, US23200202, US23200203, US23200204, US23200205, US23200206, 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Distribution pattern: Worldwide distribution. US nationwide, Australia, Austria, Denmark, France, Germany, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and England

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notification was sent August 22, 2014.