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.
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. 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
Related recalls
Same manufacturer · Invivo Corporation
See all →- LowInvivo MR Coils Recalled for Incorrect IPX1 Water Ingress Rating Label
FDA (Devices) · 2020-10-28
- HighInvivo Recalls MRI Monitor Adapters Due to Insufficient Shielding
FDA (Devices) · 2020-03-11
- HighInvivo Xper Flex Cardio Physiomonitoring System Software Recall
FDA (Devices) · 2018-11-21
- HighInvivo Xper Flex Cardio Physiomonitoring System Recalled for Firmware Error
FDA (Devices) · 2018-09-26
- ModerateInvivo Xper Flex Cardio Physiomonitoring System Recalled for Software Defect
FDA (Devices) · 2018-06-13
Same hazard · measurement failure
See all →- HighStryker Precision Thin Blade Attachments Recalled for Measurement Failure
FDA (Devices) · 2025-02-19
- HighFDA Recalls Sensis Cardiac Diagnostic Systems for Software Measurement Error
FDA (Devices) · 2022-01-26
- HighPhilips IntelliVue G7m Anesthesia Gas Module Firmware Recall
FDA (Devices) · 2020-07-29
- HighMediana Attendant Vital Signs Monitor Recalled for Temperature Measurement Failures
FDA (Devices) · 2020-07-08
- HighPhilips IntelliVue Monitors Recalled for NBP Measurement Stoppage
FDA (Devices) · 2014-10-29
Similar recalls
- HighInvivo Recalls Philips Expression MR200 MRI Patient Monitoring Systems
FDA (Devices) · 2015-01-21
- HighInvivo Recalls Philips MRI Patient Monitoring Systems Due to Metal Debris
FDA (Devices) · 2014-10-08
- ModeratePhilips Recalls MRI Patient Monitoring Systems Due to Incorrect Calibration Instructions
FDA (Devices) · 2020-04-08
- ModeratePhilips Invivo Expression MRI Patient Monitoring System Labeling Recall
FDA (Devices) · 2015-08-05
- ModerateInvivo Recalls Philips Expression IP5 MRI Patient Monitoring Units
FDA (Devices) · 2016-09-28
- HighInvivo Xper Flex Cardio Patient Monitoring System Recalled for Frozen Display
FDA (Devices) · 2016-09-14