CLASS I Device recall · Reported 31 Jul 2013 · FDA Enforcement Report
Optima NM/CT recalled by GE Healthcare
GE Healthcare is recalling Optima NM/CT 640, distributed nationwide in the US. The recall was initiated on 13 Jun 2013 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1793-2013
- FDA event ID
- 65579
- Recalling firm
- GE Healthcare, Waukesha, WI
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 13 Jun 2013
- FDA classified
- 23 Jul 2013
- Reported
- 31 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 13 Jun 2013 | Recall initiated by company | |
| 23 Jul 2013 | Classified by FDA | +40 days |
| 31 Jul 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 65579This product is part of a recall event; the main page for the event is Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring recalled | GE Healthcare | Other | Nationwide | |
| CLASS I | Discovery NM/CT 670 dual detector free-geometry integrated recalled | GE Healthcare | Device Malfunction | Nationwide | |
| CLASS I | Varicam/VG and VG Hawkeye devices recalled by GE Healthcare | GE Healthcare | Other | Nationwide | |
| CLASS I | Brivo NM615, is an all-purpose recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide | |
| CLASS I | Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma recalled | GE Healthcare | Other | Nationwide | |
| CLASS I | Discovery NM 630, dual detector free-geometry integrated recalled | GE Healthcare | Device Malfunction | Nationwide |
More recalls from GE Healthcare
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|---|---|---|---|---|---|
| Device | CLASS II | Signa Premier systems recalled by GE Healthcare | GE Healthcare | Other | Nationwide |
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| Device | CLASS II | GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological recalled | GE Healthcare | Device Malfunction | |
| Device | CLASS II | Centricity Pacs-iw (Pacs-iw) recalled by GE Healthcare | GE Healthcare | Other | IL |
| Device | CLASS II | Centricity Pacs-iw with Universal Viewer recalled by GE Healthcare | GE Healthcare | Other | IL |
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| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |