FDA Device Recall Z-0001-2015: Invivo Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0001-2015.

Recall Res Number

Z-0001-2015

Recalling Firm / Manufacturer

Invivo Corporation

FEI Number

1051786

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2014-09-08

Date Posted

2014-10-01

Date Terminated

2017-01-09

Product Code

MWI

Event Number

69192

Product Quantity

10 units

Product Description Philips Expression MR200 MRI Patient Monitoring System Model 866120

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.

Action Details The firm, Philips Healthcare, sent an "URGENT- Medical Device Recall" letter dated June 17, 2014, to its customers informing them of the product, problem and actions taken. The firm informed the customers that there are no additional actions required on their part. The Philips/Invivo Account Manager will contact them in order to arrange for replacement of the device. If you need any further information or support concerning this issue, contact your local Philips/Invivo representative: 877-468-4861 option 1, then option 2.

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

Code Information / Serial Numbers Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013

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ANALOG DEVICES Registration: 3000130829 View Registration
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Medical Device Recall: Z-0001-2015

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer