Z-1430-2022 Class II Ongoing
FDA device recall Z-1430-2022 was initiated by GE Healthcare, LLC on Jun 24, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 52.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 27, 2022
- Initiation Date
- Jun 24, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52
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.
Distribution Pattern
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.
Code Information
SIGNA Premier GTINs: 00840682135269 and 00195278010797
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1430-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026