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.
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling 62 SIGNA Pioneer Nuclear Magnetic Resonance Imaging Systems worldwide due to a potential installation workflow issue that could result in the MR system's date and time being set incorrectly. Because the system's date and time settings populate the DICOM header information on medical images, an incorrect date could be recorded on those images. The affected devices are distributed across the United States and internationally in Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and the United Kingdom, with 30 units in the US and 32 outside the US.
The recall notice does not specify a remedy or corrective action for consumers who may have one of these affected systems.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US nationwide distribution and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom. Quantity: 62 (30 US, 32 OUS) total devices Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.