Invivo Corporation: Medical Device Recall in 2014 - (Recall #: Z-0001-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Philips Expression MR200 MRI Patient Monitoring System Model 866120

Product Classification:

Class II

Date Initiated: September 8, 2014

Date Posted: October 8, 2014

Recall Number: Z-0001-2015

Event ID: 69192

Reason for Recall:

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.

Status: Terminated

Product Quantity: 10 units

Code Information:

Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013

Distribution Pattern:

Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden.

Voluntary or Mandated:

Voluntary: Firm initiated