Z-2057-2021Class II

SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Name: Z-2057-2021 SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Creator: GE Healthcare, LLC
Published: 2021-06-04
License: https://open.fda.gov/license/

GE Healthcare / initiated 2021-06-04 / Open, Classified / root cause: software

FDA source

GE Healthcare, LLC began a recall of SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance on 2021-06-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2057-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-06-04
Posted: 2021-07-12
Recalling firm: GE Healthcare
Product: SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Product code: OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 71 devices
Distribution: Worldwide distributions.
Product codes and lots: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2057-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2052-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12
Z-2053-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12
Z-2054-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12
Z-2055-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12
Z-2056-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12
Z-2057-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12
Z-2058-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12
Z-2059-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12
Z-2060-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12
Z-2061-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12
Z-2062-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12
Z-2063-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12
Z-2064-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12
Z-2065-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12

Product code OUO

K163619Class IISigna Pet/mrGe Medical Systems, LLC / cleared 2017-02-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)