The Recall Desk
ModerateFDA (Devices)·Z-2867-2016·Announced 2016-09-28

Invivo Recalls Philips Expression IP5 MRI Patient Monitoring Units

Invivo Corporation is recalling 639 Philips Expression Information Portal (IP5) units because display numerics may freeze and menu keys may disable after extended run time.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses, injuries, or hospitalizations, and the defect involves a display malfunction rather than a direct physical hazard, fitting the criteria for a moderate severity score.

Plain-English summary

Invivo Corporation is recalling 639 units of the Philips Expression Information Portal (IP5) Model 865471. This medical device 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.

The recall was initiated because the device may experience frozen display numerics and disabled menu keys after extended run time. The affected units were distributed worldwide, including in the United States, Australia, Austria, Denmark, France, Germany, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and England.

A customer notification regarding this issue was sent on August 22, 2014. The source text does not specify the corrective action required for consumers or healthcare facilities, nor does it report any illnesses or injuries associated with the defect.

The recalled product

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.
Manufacturer
Invivo Corporation
Affected units
639

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial numbers US23200121
  • US23200122
  • US23200123
  • US23200124
  • US23200125
  • US23200126
  • US23200127
  • US23200128
  • US23200129
  • US23200130
  • US23200131
  • US23200132
  • US23200133
  • US23200134
  • US23200135
  • US23200136
  • US23200137
  • US23200138
  • US23200139
  • US23200140

Distribution

Distributed nationwide across the United States.