GE Healthcare: When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.

Agency Publication Date: November 10, 2015

Affected Products

Product: GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging.

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Product: GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa VH/i MR Imaging System. The Transmit/Receive Body Imaging Coil is intended for imaging of the Neck, Spine, Abdomen/Thorax and the extremities.

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Product: GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.

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Product: GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR safe biopsy needles.

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Product: GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging device.

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Product: GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device.

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00000269454MR5 NO1005MR02 00001009BD6579 2887688HDX DUMFMI60876070 PL3040MR01 00000001526M23 PER08626 00001003BD640D PER28007 00000300683MR0 PER19516 00000938BD5F14 RO1189MR01 00000292316MR7 RU1971MR02 00000293651MR6 RU1688MR01 00000279146MR5 ZA2222MR01 00000265005MR9 DPM32124 00001006BD6463 DEL26444 00000299314MR5 NPV84502 00000300685MR5 ME051580 00000009454YR0 DPC79014 SY2012MR02 000000HDMR3898 0853270090 00000289162MR0 0853270094 00000298690MR9 00149MRS01 00624MRS04

Product: GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high-resolution physiologic and anatomic information, acquired simultaneously and isocentrically.

00000000UA0064 415723SHMRW 00000000UA0217 415CBMRP N/A 608262PETMR1 MAYOPETMR01 UABPETMR SID TBD SID TBD 262574PETMR1 310974MR1 MRUA0459 309452MR1 082427HWBAY1 M40345211 N/A SID TBD SID TBD SID TBD 00001309FMM076 C001MR01 00000309668MR2 AC001MR02 00000307417MR6 120810MR03

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 72301

Status: Resolved

Manufacturer: GE Healthcare

Manufactured In: United States

Units Affected: 7 products (756; 19; 55; 97; 350; 215; 17)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.

Product: GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging device.

Product: GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device.