Z-0753-2016Class II

GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic...

Name: Z-0753-2016 GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic...
Creator: Regulatory Insight, Inc
Published: 2008-07-01
License: https://open.fda.gov/license/

Regulatory Insight, Inc. / initiated 2008-07-01 / Terminated

FDA source

Regulatory Insight, Inc began a recall of GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy... on 2008-07-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0753-2016
Classification: Class II
Status: Terminated
Initiated: 2008-07-01
Posted: 2016-02-24
Terminated: 2017-07-11
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.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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.
FDA 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 in commerce: 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.
Product codes and lots: NRT no.: 02980000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0753-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0753-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24

Product code OWB

K033486Class IIGe Precision MpiNrt-Nordisk Rontgen Teknik A/S / cleared 2003-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)