SIGNA Premier magnetic resonance scanner, model 5748519.
Reported: July 27, 2022 Initiated: June 24, 2022 #Z-1430-2022
Product Description
SIGNA Premier magnetic resonance scanner, model 5748519.
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.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 52
- 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.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
SIGNA Premier magnetic resonance scanner, model 5748519.. Recalled by GE Healthcare, LLC. Units affected: 52.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 27, 2022. Severity: Moderate. Recall number: Z-1430-2022.
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