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GE Healthcare, LLC Recall 90587

Description: SIGNA Premier magnetic resonance scanner, model 5748519.

GE Healthcare, LLC Recall 90587 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1430-2022
Event ID90587
Event DescriptionSIGNA Premier magnetic resonance scanner, model 5748519.
Product TypeDevices
DistributionWorldwide 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.
Recall ReasonUnder 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.
Device Classification20220727
Device Code InfoSIGNA Premier GTINs: 00840682135269 and 00195278010797
Center Classification Date20220721
Recall Initiation Date20220624
Recalling FirmGE Healthcare, LLC
Initial Notification Letter
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