Z-0945-2011

GE Healthcare Discovery RX (16 slice) PET/CT System; Discovery RX (16 Slice) PET/CT Systems with technical...

Name: Z-0945-2011 GE Healthcare Discovery RX (16 slice) PET/CT System; Discovery RX (16 Slice) PET/CT Systems with technical...
Creator: GE Healthcare, LLC
Published: 2010-10-27
License: https://open.fda.gov/license/

GE Healthcare / initiated 2010-10-27 / Terminated

FDA source

GE Healthcare, LLC began a recall of GE Healthcare Discovery RX (16 slice) PET/CT System; Discovery RX (16 Slice) PET/CT Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx... on 2010-10-27. The reason FDA records is "Although the system x-ray output is accurate for the technique factors given, and the dose display is also accurate, certain CTDI adjustment factors used for the manual calculation from the Technical Reference Manual...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0945-2011
Status: Terminated
Initiated: 2010-10-27
Posted: 2011-02-07
Terminated: 2012-07-13
Recalling firm: GE Healthcare
Product: GE Healthcare Discovery RX (16 slice) PET/CT System; Discovery RX (16 Slice) PET/CT Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Although the system x-ray output is accurate for the technique factors given, and the dose display is also accurate, certain CTDI adjustment factors used for the manual calculation from the Technical Reference Manual (TRM) are incorrect. CTDI100 Aperture Adjustment Factors for 4x0.625 mode contain incorrect values. This issue may lead to inaccurate CTDI manual calculation. The results of the diffe
FDA root cause: Radiation Control for Health and Safety Act
Action: An Important Electronic Product Radiation Warning letter will be provided together with the TRM addendum informing the customers of the issue and related hazards. The letter also identified the affected product and gave instructions, which include referring to the TRM addendum, along with the product correction. This correction will be executed via a Field Modification Instruction IFMI 254281 released in November, 2010 with an estimated completion date of May, 2011. Questions or concerns should be directed to the call numbers listed or a local GE Healthcare Service Representative for countries not listed.
Quantity in commerce: 1450 units total in US
Distribution: Worldwide Distribution
Product codes and lots: Technical Reference Manual numbers 2351785-xxx and 2390935-xxx.

Product code JAK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)