Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
Check against the official notice below — it lists the full affected range.
GE Healthcare, LLC has recalled 10 Signa 1.5T TwinSpeed Magnetic Resonance Imaging Systems distributed worldwide due to a potential defect where images may be flipped left to right. The affected systems have the following IDs: MMIMR01, 213748HDMR, 714125MR, 561218MR, 918523MR1, 304766MR1, 082427030026, 082427080007, 082427020017, and 376569401MR. These systems were distributed across numerous countries including the United States, Canada, and various nations in Europe, Asia, the Middle East, Africa, and South America.
The record does not specify what remedy is available or what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
There is potential for the images to be flipped left to right.
Reason for recall: There is potential for the images to be flipped left to right. Distribution: Worldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, China, Denmark, Ecuador, Ethiopia, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Italy, Japan, Korea, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syr Quantity: 10 units Lot/code info: System IDs: MMIMR01, 213748HDMR, 714125MR, 561218MR1, 918523MR1,304766MR1, 082427030026, 082427080007, 082427020017, 376569401MR
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.