Z-1793-2013Class I

Optima NM/CT 640

Name: Z-1793-2013 Optima NM/CT 640
Creator: GE Healthcare, LLC
Published: 2013-06-13
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-06-13 / Terminated / root cause: design

FDA source

GE Healthcare, LLC began a recall of Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer... on 2013-06-13. FDA classified it as Class I and gives the reason as "GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE...". 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-1793-2013
Classification: Class I
Status: Terminated
Initiated: 2013-06-13
Posted: 2013-07-24
Terminated: 2014-06-19
Recalling firm: GE Healthcare
Product: Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re
Root cause tag: design
FDA root cause: Device Design
Action: GE sent an Urgent Medical Device Correction letter dated June 17, 2013 to all affected customers. The letter identified the affected product, recommended that qualified service personnel maintain the equipment and that Preventative Maintenance procedures are executed according to labeling. Also the Safety Chapter Sections should be re-reviewed with personnel to ensure proper operation of the equipment. GE notified customers again on July 03, 2013, via Urgent Medical Device Recall letter (including confirmation of delivery for US customers) and follow-up telephone call. Customers were instructed to cease using the affected system until GE Healthcare Field Engineer can complete an inspection of the system and perform any necessary repairs at no cost. A GE Healthcare representative will contact the hospitals to arrange for the inspection.
Quantity in commerce: 25
Distribution: Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.
Product codes and lots: System ID: 0910263253, 0910263256, 00139NUC08, 00162NUC11, 030232NU15, 215728OPT640, 262574O640, 270956NM640, 410543NUC640, 715735OPT1, 717782640NM, 808485NM640, 815564O640, 816234D640, 817250NM640, 847872O640, 901516GO640, 915839NU01, 928214NMCT, A5366308, A5639613, BD003NU01, DK1054NM03, RTD0782, XM203401.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1793-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1787-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-23
Z-1788-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-23
Z-1789-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-23
Z-1790-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-23
Z-1791-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-23
Z-1792-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-23
Z-1793-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-23

Product code KPS

K121019Class IIOptima Nm/ct 640GE Healthcare / cleared 2012-04-19

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)