FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: 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, head and body CT diagnostic imaging applications, as well as attenuation correction and anatomical localization. The Discovery product is a SPECT-CT system. It consists of two back-to-back gantries, the NM Gantry, carrying solid state Cadmium Zinc Telluride (CZT) detectors, the CT Gantry, a single patient table, power distribution unit (PDU), NMV integrated power supply (IPS) , two operator consoles with two acquisition systems (Nuclear and CT), interconnecting cables and associated accessories (ECG gating, etc.).
- Recall number
- Z-1967-2013
- Recalling firm
- GE Healthcare, LLC
- 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, head and body CT diagnostic imaging applications, as well as attenuation correction and anatomical localization. The Discovery product is a SPECT-CT system. It consists of two back-to-back gantries, the NM Gantry, carrying solid state Cadmium Zinc Telluride (CZT) detectors, the CT Gantry, a single patient table, power distribution unit (PDU), NMV integrated power supply (IPS) , two operator consoles with two acquisition systems (Nuclear and CT), interconnecting cables and associated accessories (ECG gating, etc.).
- Status
- Terminated
- Initiated
- 2013-04-10
- Posted
- 2013-08-20
- Terminated
- 2014-01-21
- Reason
- GE Healthcare has recently become aware of an incident where the wrong part of the patient body was scanned during a CT standalone exam with the Discovery NM/CT 570c
- Root cause
- Radiation Control for Health and Safety Act
- Action
- GE Healthcare will remedy the issue or bring the product into compliance with each applicable Federal standard. GE Healthcare has provided field modification instructions (FMI) to update software for the Discovery NM/CT570c hybrid system. The software update will correct the incorrect positioning of the table not prescribed by the operator. The FMI includes: A software upgrade with foreign language support to be installed in the affected models listed above, Labels (FMI label and packing label), Software upgrade workflow procedure with functional verification for all modes of operation, and Certification Report, Postponement of Medical Device Correction, Rejection of Medical Device Correction, or Refusal and/or Location Unknown Documentation. For further questions please call (262) 513-4122.
- Quantity
- 10 Systems
- Distribution
- US Distribution in the state of CT.
- Lot, serial or model codes
- Part numbers H3000SA UFC Cardiac SPECT System, H3001JA UFC Gantry, H3001JE UFC VCT Connecting Kit, H3001JF DISCOVERY NMV/CT 570C Connecting Kit.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28