The Recall Desk
ModerateFDA (Devices)·Z-1049-2016·Announced 2016-03-16

GE Medical Systems Recalls CT and PET CT Scanners for Incorrect Torque Values

GE Medical Systems is recalling 817 CT and PET CT scanner systems worldwide because service manuals contained incorrect torque values.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a moderate risk. The hazard involves incorrect documentation (torque values) rather than a direct, immediate physical defect causing reported injuries or deaths, fitting the criteria for a moderate severity score.

Plain-English summary

GE Medical Systems, LLC is recalling 817 units of various CT and PET CT scanner systems, including the Discovery LS, LightSpeed 4.0, and Discovery ST models. The recall was initiated because the Service Manuals for these devices contained an incorrect torque value.

The affected devices were distributed worldwide, including in the United States (excluding North Dakota, Vermont, and Wyoming) and numerous foreign countries. The recall covers specific serial numbers and system IDs listed in the official agency records.

Healthcare facilities and users of these devices should contact GE Medical Systems to obtain the updated Service Manuals with the correct torque specifications. This action is intended to ensure the devices are serviced and maintained according to the correct technical standards.

The recalled product

Product
Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corre
Affected units
817

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 6 recalled by GE Medical Systems, LLC 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 →

Same hazard · incorrect documentation

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