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.
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 3/5 (High).
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…
- Manufacturer
- Invivo Corporation
- Hazard
- 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
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