Philips Expression MR200 (Invivo) – Metal Debris Risk (2014)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips Expression MR200 MRI Patient Monitoring System Model 866120
Brand
Invivo Corporation
Lot Codes / Batch Numbers
Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013
Products Sold
Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013
Invivo Corporation is recalling Philips Expression MR200 MRI Patient Monitoring System Model 866120 due to During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris cou. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to power up or loss of power. This could result in the loss of monitoring and a delay in diagnosis of the patient.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IN
Page updated: Jan 10, 2026