GE Healthcare Recalls Discovery NM/CT 570c Systems for Scanning Error
GE Healthcare is recalling 10 Discovery NM/CT 570c systems in Connecticut after an incident where the wrong part of a patient's body was scanned during a CT exam.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where an error occurred (wrong body part scanned), but the source text does not explicitly report injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
GE Healthcare, LLC is recalling 10 units of the Discovery NM/CT 570c CT Standalone Scan system. This hybrid system combines a cardiac dedicated nuclear imaging subsystem and a LightSpeed GE CT subsystem, intended for cardiac Nuclear Medicine diagnostic imaging, head and body CT diagnostic imaging, and attenuation correction. The affected units are distributed in the state of Connecticut.
The recall was initiated after GE Healthcare became aware of an incident where the wrong part of the patient's body was scanned during a CT standalone exam. The specific part numbers associated with the recall include H3000SA UFC Cardiac SPECT System, H3001JA UFC Gantry, H3001JE UFC VCT Connecting Kit, and H3001JF DISCOVERY NMV/CT 570C Connecting Kit.
Healthcare facilities that have these systems should contact GE Healthcare for further instructions on how to proceed. The source text does not specify if any patients were injured or if specific corrective actions have been taken beyond the recall notification.
The recalled product
- Product
- The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging subsystem and LightSpeed GE CT subsystem. This system is intended for cardiac Nuclear Medicine (NM) diagnostic imaging applications…
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 10
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 (4)
- Part numbers H3000SA UFC Cardiac SPECT System
- H3001JA UFC Gantry
- H3001JE UFC VCT Connecting Kit
- H3001JF DISCOVERY NMV/CT 570C Connecting Kit.
Distribution
Distributed in 1 state:
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