Invivo Expression Information Portal Recalled for Audio Failure
Invivo Corporation is recalling the Expression Information Portal (Model IP5) because the device may fail to produce audio upon power up.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific defect is a failure to produce audio, which is a functional issue rather than a direct physical hazard like fire or shock, fitting the Moderate severity criteria for a device defect without reported injuries.
Plain-English summary
Invivo Corporation is recalling the Expression Information Portal (Model IP5). The device is a secondary display control unit intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures. It is used in MR control rooms, induction rooms, or recovery rooms to output measured patient data to a hospital information system.
The recall is being issued because the IP5 may fail to produce audio upon power up. This defect could affect the ability of medical staff to receive audio alerts or data during patient monitoring.
The recall involves 299 units distributed worldwide, including the United States (nationwide), Australia, Austria, Denmark, France, Germany, Netherlands, Poland, Singapore, Sweden, Switzerland, and the United Kingdom. Specific serial numbers are listed in the official recall documentation. Health care facilities should contact Invivo Corporation for instructions on how to resolve the issue.
The recalled product
- Product
- Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI procedure from the MR control room, induction room, or recovery room and then outputs…
- Manufacturer
- Invivo Corporation
- Hazard
- Affected units
- 299
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)
- Model 865471 Lot or serial Numbers: US23200154
- US23200155
- US23200156
- US23200157
- US23200158
- US23200159
- US23200160
- US23200161
- US23200162
- US23200163
- US23200164
- US23200165
- US23200166
- US23200167
- US23200168
- US23200169
- US23200170
- US23200172
- US23200173
- US23200176
Distribution
Distributed nationwide across the United States.
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