PlainRecordsFDA · Medical device recall
SIGNA Premier… and 13 more products
- Date
- July 21, 2021
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): 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)
- Status
- Ongoing
- Filed by
- GE Healthcare, LLC
- Reason
- GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
- Distribution pattern
- Worldwide distributions.
14 products in this recall
SIGNA Premier…
- Product
- SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- Quantity
- 100 devices
- Codes and lots
- Not Available
- Recall started
- June 4, 2021
- Device type
- System, Nuclear Magnetic Resonance Imaging
- Root cause (FDA)
- Software design
- What the company told customers
- Deployment of the original customer letter to consignees in the U.S. began on June 4, 2021. Dissemination of the updated customer letter to consignees in the U.S. began on June 11, 2021. The letters discuss an issue on the affected products listed below where the Patient Orientation button may inadvertently be clicked when intending to click on the Save RX button. Users are directed to review and confirm that the actual patient orientation matches the prescribed patient orientation before initiating the scan. A correction is planned.
- Recall number
- Z-2052-2021
SIGNA Architect…
- Product
- SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- Quantity
- 311 devices
- Recall started
- June 4, 2021
- Device type
- System, Nuclear Magnetic Resonance Imaging
- Root cause (FDA)
- Software design
- What the company told customers
- Deployment of the original customer letter to consignees in the U.S. began on June 4, 2021. Dissemination of the updated customer letter to consignees in the U.S. began on June 11, 2021. The letters discuss an issue on the affected products listed below where the Patient Orientation button may inadvertently be clicked when intending to click on the Save RX button. Users are directed to review and confirm that the actual patient orientation matches the prescribed patient orientation before initiating the scan. A correction is planned.
- Recall number
- Z-2053-2021
SIGNA Pioneer…
- Product
- SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- Quantity
- 460 units
- Recall started
- June 4, 2021
- Device type
- System, Nuclear Magnetic Resonance Imaging
- Root cause (FDA)
- Software design
- What the company told customers
- Deployment of the original customer letter to consignees in the U.S. began on June 4, 2021. Dissemination of the updated customer letter to consignees in the U.S. began on June 11, 2021. The letters discuss an issue on the affected products listed below where the Patient Orientation button may inadvertently be clicked when intending to click on the Save RX button. Users are directed to review and confirm that the actual patient orientation matches the prescribed patient orientation before initiating the scan. A correction is planned.
- Recall number
- Z-2054-2021
Discovery MR750w 3.0T…
- Product
- Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- Quantity
- 585 devices
- Recall started
- June 4, 2021
- Device type
- System, Nuclear Magnetic Resonance Imaging
- Root cause (FDA)
- Software design
- What the company told customers
- Deployment of the original customer letter to consignees in the U.S. began on June 4, 2021. Dissemination of the updated customer letter to consignees in the U.S. began on June 11, 2021. The letters discuss an issue on the affected products listed below where the Patient Orientation button may inadvertently be clicked when intending to click on the Save RX button. Users are directed to review and confirm that the actual patient orientation matches the prescribed patient orientation before initiating the scan. A correction is planned.
- Recall number
- Z-2055-2021
Discovery MR750 3.0T…
- Product
- Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- Quantity
- 248 units
- Recall started
- June 4, 2021
- Device type
- System, Nuclear Magnetic Resonance Imaging
- Root cause (FDA)
- Software design
- What the company told customers
- Deployment of the original customer letter to consignees in the U.S. began on June 4, 2021. Dissemination of the updated customer letter to consignees in the U.S. began on June 11, 2021. The letters discuss an issue on the affected products listed below where the Patient Orientation button may inadvertently be clicked when intending to click on the Save RX button. Users are directed to review and confirm that the actual patient orientation matches the prescribed patient orientation before initiating the scan. A correction is planned.
- Recall number
- Z-2056-2021
Signa Pet/Mr…
- Product
- SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
- Quantity
- 71 devices
- Recall started
- June 4, 2021
- Device type
- Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
- Root cause (FDA)
- Software design
- What the company told customers
- Deployment of the original customer letter to consignees in the U.S. began on June 4, 2021. Dissemination of the updated customer letter to consignees in the U.S. began on June 11, 2021. The letters discuss an issue on the affected products listed below where the Patient Orientation button may inadvertently be clicked when intending to click on the Save RX button. Users are directed to review and confirm that the actual patient orientation matches the prescribed patient orientation before initiating the scan. A correction is planned.
- Recall number
- Z-2057-2021
SIGNA Creator…
- Product
- SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System
- Quantity
- 1737 devices
- Recall started
- June 4, 2021
- Device type
- System, Nuclear Magnetic Resonance Imaging
- Root cause (FDA)
- Software design
- What the company told customers
- Deployment of the original customer letter to consignees in the U.S. began on June 4, 2021. Dissemination of the updated customer letter to consignees in the U.S. began on June 11, 2021. The letters discuss an issue on the affected products listed below where the Patient Orientation button may inadvertently be clicked when intending to click on the Save RX button. Users are directed to review and confirm that the actual patient orientation matches the prescribed patient orientation before initiating the scan. A correction is planned.
- Recall number
- Z-2058-2021
Signa Mr355…
- Product
- SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System
- Quantity
- 242 units
- Recall started
- June 4, 2021
- Device type
- System, Nuclear Magnetic Resonance Imaging
- Root cause (FDA)
- Software design
- What the company told customers
- Deployment of the original customer letter to consignees in the U.S. began on June 4, 2021. Dissemination of the updated customer letter to consignees in the U.S. began on June 11, 2021. The letters discuss an issue on the affected products listed below where the Patient Orientation button may inadvertently be clicked when intending to click on the Save RX button. Users are directed to review and confirm that the actual patient orientation matches the prescribed patient orientation before initiating the scan. A correction is planned.
- Recall number
- Z-2059-2021
Signa Mr380…
- Product
- SIGNA MR380, Nuclear Magnetic Resonance Imaging System
- Recall started
- June 4, 2021
- Device type
- System, Nuclear Magnetic Resonance Imaging
- Root cause (FDA)
- Software design
- What the company told customers
- Deployment of the original customer letter to consignees in the U.S. began on June 4, 2021. Dissemination of the updated customer letter to consignees in the U.S. began on June 11, 2021. The letters discuss an issue on the affected products listed below where the Patient Orientation button may inadvertently be clicked when intending to click on the Save RX button. Users are directed to review and confirm that the actual patient orientation matches the prescribed patient orientation before initiating the scan. A correction is planned.
- Recall number
- Z-2060-2021
SIGNA Artist…
- Product
- SIGNA Artist, Nuclear Magnetic Resonance Imaging System
- Quantity
- 562 devices
- Recall started
- June 4, 2021
- Device type
- System, Nuclear Magnetic Resonance Imaging
- Root cause (FDA)
- Software design
- What the company told customers
- Deployment of the original customer letter to consignees in the U.S. began on June 4, 2021. Dissemination of the updated customer letter to consignees in the U.S. began on June 11, 2021. The letters discuss an issue on the affected products listed below where the Patient Orientation button may inadvertently be clicked when intending to click on the Save RX button. Users are directed to review and confirm that the actual patient orientation matches the prescribed patient orientation before initiating the scan. A correction is planned.
- Recall number
- Z-2061-2021
SIGNA Voyager…
- Product
- SIGNA Voyager, Nuclear Magnetic Resonance Imaging System
- Quantity
- 541 devices
- Recall started
- June 4, 2021
- Device type
- System, Nuclear Magnetic Resonance Imaging
- Root cause (FDA)
- Software design
- What the company told customers
- Deployment of the original customer letter to consignees in the U.S. began on June 4, 2021. Dissemination of the updated customer letter to consignees in the U.S. began on June 11, 2021. The letters discuss an issue on the affected products listed below where the Patient Orientation button may inadvertently be clicked when intending to click on the Save RX button. Users are directed to review and confirm that the actual patient orientation matches the prescribed patient orientation before initiating the scan. A correction is planned.
- Recall number
- Z-2062-2021
Optima MR450w 1.5T…
- Product
- Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
- Quantity
- 1519 units
- Recall started
- June 4, 2021
- Device type
- System, Nuclear Magnetic Resonance Imaging
- Root cause (FDA)
- Software design
- What the company told customers
- Deployment of the original customer letter to consignees in the U.S. began on June 4, 2021. Dissemination of the updated customer letter to consignees in the U.S. began on June 11, 2021. The letters discuss an issue on the affected products listed below where the Patient Orientation button may inadvertently be clicked when intending to click on the Save RX button. Users are directed to review and confirm that the actual patient orientation matches the prescribed patient orientation before initiating the scan. A correction is planned.
- Recall number
- Z-2063-2021
Discovery MR450 1.5T…
- Product
- Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
- Quantity
- 40 units
- Recall started
- June 4, 2021
- Device type
- System, Nuclear Magnetic Resonance Imaging
- Root cause (FDA)
- Software design
- What the company told customers
- Deployment of the original customer letter to consignees in the U.S. began on June 4, 2021. Dissemination of the updated customer letter to consignees in the U.S. began on June 11, 2021. The letters discuss an issue on the affected products listed below where the Patient Orientation button may inadvertently be clicked when intending to click on the Save RX button. Users are directed to review and confirm that the actual patient orientation matches the prescribed patient orientation before initiating the scan. A correction is planned.
- Recall number
- Z-2064-2021
1.5T SIGNA HDxt (HD28) MR System…
- Product
- 1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
- Quantity
- 91 units
- Recall started
- June 4, 2021
- Device type
- System, Nuclear Magnetic Resonance Imaging
- Root cause (FDA)
- Software design
- What the company told customers
- Deployment of the original customer letter to consignees in the U.S. began on June 4, 2021. Dissemination of the updated customer letter to consignees in the U.S. began on June 11, 2021. The letters discuss an issue on the affected products listed below where the Patient Orientation button may inadvertently be clicked when intending to click on the Save RX button. Users are directed to review and confirm that the actual patient orientation matches the prescribed patient orientation before initiating the scan. A correction is planned.
- Recall number
- Z-2065-2021
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-2052-2021, Z-2053-2021, Z-2054-2021, Z-2055-2021, Z-2056-2021, Z-2057-2021, Z-2058-2021, Z-2059-2021 and others. The agency record governs; check it and the company before acting.