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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
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