FDA Medical Device Recalls (openFDA)
Regulatory Insight, Inc: GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
- Recall number
- Z-0753-2016
- Recalling firm
- Regulatory Insight, Inc
- Product
- GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
- Status
- Terminated
- Initiated
- 2008-07-01
- Posted
- 2016-02-24
- Terminated
- 2017-07-11
- Reason
- It was discovered that the Remote Touch Panel (RTP) of the GE Precision MPi X-ray system may not always boot up as intended and needs to be updated to properly accomplish its intended purpose.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Nordisk Rontgen Teknik ( NRT ) Planned action to bring defect into compliance: 1.Nordisk Rontgen Teknik A/S (NRT) will contact customers and initiate a software and hardware update to correct the defect. 2.NRT engineers will install the software and perform testing to ensure the software and hardware update was effective. 3.The customer notification letter which includes a statement that NRT will without charge, remedy the defect or bring the product into compliance. For further questions please call (720) 962- 5412.
- Quantity
- 43
- Distribution
- US Distribution to the states of :TN, CA, WA, OR, PA, WI, FL, MN, VT, NY, NV, MA, CO, IN, MI, MS and OH.
- Lot, serial or model codes
- NRT no.: 02980000
- 510(k) numbers
- ["K033486"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 3011361886
- Firm city
- Littleton
- Firm state
- CO
- 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