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.
This recall has been terminated (originally issued September 14, 2014).
- Company
- Invivo Corporation
- Recall Initiated
- September 14, 2014
- Terminated
- December 14, 2016
- Recall Number
- Z-2867-2016
- Quantity
- 639 units
- Firm Location
- Orlando, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notification was sent August 22, 2014.
Distribution
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
Lot / Code Info
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, US23200207, US23200208, 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US34600804, US34600805, US41600814, US41600815, US41600816, US41600817, US41600818, US41600819, US41600820, US41600821, US41600822, US41600823, US41600824, US41600825, US41600826, US41600827, US41600828, US41600829, US41600830, US41600831, US41600832, US41600833, US41600834, US41600835, US41600836, US41600837, US41600838, US41600839, US41600840, US41600841, US41600842, US41600843, US41600844, US41600845, US41600846, US41600847, US41600848, US41600849, US41600850, US41600851, US41600852, US41600853, US41600854, US41600855, US41600856, US41600857, US41600858, US41600859, US41600860, US41600861, US41600862, US41600863, US41600865, US41600866, US41600867, US41600868, US41600869, US41600870, and US41600871.
Root Cause
Software in the Use Environment
Action Taken
A recall notification letter was sent to hospitals who purchased the recalled product via UPS March 2014. The letter instructed users to power cycle the IP5 unit every day. This is done by pressing the power button on the side of the unit. Customers were instructed to communicate the recall to all those subject and to attach an addendum to the IP5 Instructions for Use. The firm advised customers to call their Philips representative, option 1, then option 2, if they had any questions or concerns.