Invivo Recalls Philips Expression MR200 MRI Patient Monitoring Systems
Invivo Corporation is recalling 24 Philips Expression MR200 MRI Patient Monitoring Systems because they may fail to produce Non-Invasive Blood Pressure (NIBP) measurements.
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. The hazard involves a failure to produce blood pressure measurements, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Invivo Corporation is recalling 24 units of the Philips Expression MR200 MRI Patient Monitoring System. The recall is due to a failure to produce Non-Invasive Blood Pressure (NIBP) measurements.
The affected devices are Model 866120 with specific lot numbers ranging from US33600004 to US33600028. The products were distributed worldwide, including in the United States (specifically CA, GA, MI, NJ, NV, and TX) and in Austria, Finland, Germany, Poland, Singapore, Sweden, Switzerland, and the United Kingdom.
Healthcare facilities and consumers should check their inventory for the affected model and lot numbers. If a device is affected, it should be removed from service and returned to Invivo Corporation according to their instructions.
The recalled product
- Product
- Philips Expression MR200 MRI Patient Monitoring System
- Manufacturer
- Invivo Corporation
- Hazard
- Affected units
- 24
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: 866120
- Lot numbers: US33600004
- US33600005
- US33600006
- US33600007
- US33600008
- US33600009
- US33600010
- US33600011
- US33600012
- US33600013
- US33600014
- US33600015
- US33600016
- US33600017
- US33600018
- US33600019
- US33600020
- US33600022
- US33600023
Distribution
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