Invivo Expression IP5 Information Portal Recalled for Audio Loss
Invivo Corporation is recalling 271 Expression IP5 Information Portal devices because three units lost audio during use.
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, and the specific defect (audio loss) is a functional failure without reported injuries or hospitalizations, fitting the criteria for a moderate severity recall.
Plain-English summary
Invivo Corporation is recalling 271 units of the Expression Information Portal (Model IP5). This device is a display and controller used by trained healthcare professionals to remotely monitor the vital signs of patients undergoing MRI procedures.
The recall was initiated because three different IP5 devices lost audio during use. The affected units were distributed worldwide, including in the United States, Australia, Austria, Denmark, France, Germany, Netherlands, Poland, Singapore, Sweden, Switzerland, and the United Kingdom.
Healthcare facilities should stop using the affected devices and contact Invivo Corporation for further instructions.
The recalled product
- Product
- Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression Information Portal (Model IP5) a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professional to remotely monitor the…
- Manufacturer
- Invivo Corporation
- Hazard
- Affected units
- 271
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)
- US23200113
- US23200120
- US23200121
- US23200122
- US23200123
- US23200124
- US23200125
- US23200126
- US23200127
- US23200128
- US23200129
- US23200130
- US23200131
- US23200132
- US23200133
- US23200134
- US23200135
- US23200136
- US23200137
- US23200138
Distribution
Distribution scope not specified by the agency.
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Similar recalls
- HighInvivo Recalls Philips IP5 MRI Patient Monitoring Devices
FDA (Devices) · 2014-08-27
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FDA (Devices) · 2014-02-26
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