GE Healthcare, LLC: It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.; It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system s date and time setting are used to populate the DICOM header information on

Agency Publication Date: January 28, 2020

Affected Products

Product: SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

Mfg. Lot or Serial# System ID 33-4-1031 415723SHMR19 To be provided RTD01204 To be provided DPN88672

Product: SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

Mfg. Lot or Serial # System ID PG75A1700023MR 630DMGMR3T 33-4-1252 312702MR3T 033-4-1005 518262MR750W To be provided 082427210212 To be provided 082427170026 To be provided GON4713311 To be provided M4017073 To be provided EM0601 To be provided O009MR03 To be provided GON4634845

Product: SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

Mfg. Lot or Serial # System ID To be provided GON4833100 01264 860536MR3T KZTBL1700064TJ 860871MR3T KZTBL1800069TJ RADNETMR1700 KZTBL1800022TJ 508872PMR 01302 RADNETMR1708 KZTBL1900130TJ 301698MR1 KZTBL1900071TJ 704333PIO KZTBL1900110TJ 631751MR KZTBL1900107TJ RADNETMR1707 KZTBL1900121TJ 803936LMCMR2 033-4-1532 281HMI750W To be provided 83199160995 To be provided M24313812 To be provided M2850013 To be provided TP0013MR01 To be provided PNUE04MR02 To be provided TP0008MR07 To be provided 083027823408018 To be provided 083027823888617 To be provided GON4826677 To be provided GON4762453 To be provided B5142305 To be provided ZC0002 To be provided ZC0034 To be provided ZC0001 To be provided ZC0306 To be provided GON4795546 To be provided 222768MR01 To be provided 34340MRS02 To be provided 10627MRS02

Product: SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

Mfg. Lot or Serial # System ID 22D-4-0868 901BMHCRITMR HDGOC1900010SC 209521SGMR HDGOC1900015SC 4577711MR11 002776WHF 954916MR1 022D-4-1175 808243MR 857 LONGWOOD30MR2 00000290815MR0 508580BMR3 002801WHF 734246MR 002930WHF 845279MR 00000269040MR2 412749MR1 022D-4-1125 801RIVMR2 HDGOC1900003SC 206386SMR H05114 4815915MR11 00000277443MR8 304526SMR1 To be provided GON4796599 To be provided 424881MR01 To be provided 083027829345912 To be provided 083027862100408

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84655

Status: Resolved

Manufacturer: GE Healthcare, LLC

Manufactured In: United States

Units Affected: 4 products (62 (30 US, 32 OUS) total devices)

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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

Mfg. Lot or Serial# System ID 33-4-1031 415723SHMR19 To be provided RTD01204 To be provided DPN88672