Z-1789-2012Class II

GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha...

Name: Z-1789-2012 GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha...
Creator: General Electric Med Systems LLC
Published: 2006-05-31
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-05-31 / Terminated / root cause: design

FDA source

General Electric Med Systems LLC began a recall of GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model Number: 5131070. The Revolution XR/d... on 2006-05-31. FDA classified it as Class II and gives the reason as "An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1789-2012
Classification: Class II
Status: Terminated
Initiated: 2006-05-31
Posted: 2012-06-08
Terminated: 2012-07-31
Recalling firm: GE Healthcare
Product: GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model Number: 5131070. The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath
Root cause tag: design
FDA root cause: Device Design
Action: GE Healthcare sent an "URGENT SAFETY INFORMATION" letter dated May 31, 2006 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included new operator instructions and warning labels.
Quantity in commerce: 3,796 units
Distribution: Worldwide Distribution.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1789-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1788-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-08
Z-1789-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-08
Z-1790-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-08

Product code MQB

K012389Class IIRevolution Xr/d Digital Radiographic Imaging SystemGe Medical Systems, Inc. / cleared 2001-08-10

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)