FDA Medical Device Recalls (openFDA)
Invivo Corporation: Philips Expression MR200 MRI Patient Monitoring System Model 866120
- Recall number
- Z-0001-2015
- Recalling firm
- Invivo Corporation
- Product
- Philips Expression MR200 MRI Patient Monitoring System Model 866120
- Status
- Terminated
- Initiated
- 2014-09-08
- Posted
- 2014-10-01
- Terminated
- 2017-01-09
- Reason
- 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.
- Root cause
- Material/Component Contamination
- Action
- 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.
- Quantity
- 10 units
- Distribution
- Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden.
- Lot, serial or model codes
- Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013
- 510(k) numbers
- ["K131382"]
- PMA numbers
- not on file
- Product code
- MWI
- Firm FEI
- 1051786
- Firm city
- Orlando
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28