SIGNA Premier magnetic resonance scanner, model 5748519.
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled 52 SIGNA Premier magnetic resonance scanners (model 5748519) distributed worldwide and across multiple U.S. states due to a hazard involving gradient coils. Under rare conditions, these coils could produce elevated acoustic noise during scanning operations. Prolonged exposure to this elevated noise could potentially result in hearing loss.
The affected scanners were distributed in the United States in Alabama, Arizona, California, Michigan, Minnesota, New York, and Wisconsin, as well as internationally in China, France, Hong Kong, India, Italy, Japan, Korea, Kuwait, Norway, Oman, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, and the United Kingdom. The product identification numbers are GTIN 00840682135269 and GTIN 00195278010797. The source does not specify a remedy or required consumer action.
Written by software from the official notice below. Not reviewed by a lawyer.
Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.
Reason for recall: Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss. Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, MI, MN, NY, and WI. There was government distribution but no military distribution. The countries of China, France, Hong Kong, India, Italy, Japan, Korea, Kuwait, Norway, Oman, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, and United Kingdom. Quantity: 52 Lot/code info: SIGNA Premier GTINs: 00840682135269 and 00195278010797
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.