The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-1056-2023·Announced 2023-02-15

GE Nuclear Medicine Imaging Systems detector fall hazard

GE Nuclear Medicine 600/800 series imaging systems may have faulty detectors that could fall, causing serious injury. Mitigation measures may not be properly implemented on 34 units distributed worldwide.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I classification meets the Critical severity criterion. FDA Class I indicates a serious device defect with reasonable probability of life-threatening consequences, consistent with the stated hazard of detector failure causing serious bodily injury.

Plain-English summary

GE Medical Systems Israel has issued a Class I recall affecting 34 units of Nuclear Medicine 600/800 series imaging systems, including the OPTIMA O640, DISCOVERY O640, and related models. These devices are Emission Computed Tomography systems used in medical facilities for diagnostic imaging.

The recall was issued because a required safety mitigation may not be correctly implemented. If the mitigation is not properly in place, the detector could fall, creating a risk of life-threatening bodily injury to patients, staff, or others near the equipment.

The affected units have been distributed worldwide, including throughout the United States and Puerto Rico, as well as in numerous countries internationally as documented in the FDA recall notice.

Facilities with affected equipment can verify whether their system is included by checking the serial numbers and catalog numbers listed in FDA recall notice Z-1056-2023. Affected facilities should contact GE Medical Systems Israel to ensure the required mitigation has been correctly implemented.

The recalled product

Product
GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; Emission Computed Tomography System
Manufacturer
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
34

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • a) OPTIMA O640X3/8 inch NR: Catalog number 5376204-41
  • UDI/DI Not Applicable
  • Serial Numbers: 64GY51002
  • 64GY51003
  • 64GY51004
  • 0000064GY51011
  • 64GY51005
  • b) DISCOVERY O640X 3/8 inch: Catalog number H3101RL
  • Serial Numbers: 64GY51021
  • c) NM OPTIMA O640X3/8 inch: Catalog number To be provided
  • UDI/DI To be provided
  • Serial Numbers: 26043
  • d) O640 NM Gantry 3/8 inch: Catalog number 5376204-41
  • Serial Numbers: 64GY51022
  • Serial Numbers: 64GY51024
  • 64GY51007
  • 64GY51019
  • 64GY51018
  • 64GY51016
  • 64GX51001

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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