High FDA (Devices)·Z-2270-2014·Announced 2014-08-27

Invivo Recalls Philips IP5 MRI Patient Monitoring Devices

Invivo Corporation is recalling 573 Philips IP5 Information Portal devices because a wireless function defect could interrupt communication with the host monitoring system.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a risk-of-harm product (patient monitoring) where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

Invivo Corporation is recalling 573 units of the Philips IP5 Information Portal, a display and device controller used by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures. The recall is due to a defect in the wireless function of the IP5 radio, which could be interrupted, causing a loss of wireless communication between the IP5 and the host monitoring system.

The affected devices were distributed worldwide, including nationwide in the United States and in several countries in Europe, Asia, and the Middle East. The source text does not report any injuries or illnesses associated with this defect.

Health care professionals should contact Invivo Corporation for instructions on how to resolve the issue. The recall number is Z-2270-2014.

The recalled product

Product: Philips IP5 Information Portal 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 professionals to remotely monitor the vital signs of patients undergoing MRI pro
Manufacturer: Invivo Corporation
Category: Medical Device — Patient Monitoring
Hazard: loss-of-communication
Affected units: 573

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)

Product: 865471 Number 453564251511 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.

The notice also names 45 states specifically:

Same manufacturer · Invivo Corporation

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Same hazard · loss of communication