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.
Check against the official notice below — it lists the full affected range.
GE Healthcare, LLC is recalling the SIGNA Architect Nuclear Magnetic Resonance Imaging System worldwide due to a potential installation workflow issue that could cause the system's date and time to be set incorrectly. The system's date and time settings are used to populate DICOM header information on medical images, meaning patients' images could have inaccurate dates recorded on them. A total of 62 devices have been distributed globally, including 30 units in the United States and 32 units internationally across countries including Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.
The recall involves specific system serial numbers and model identifiers listed in the manufacturer's documentation. The source document does not specify a remedy or recommended course of action for affected consumers or healthcare facilities.
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 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.