GE Healthcare, LLC: Medical Device Recall in 2022 - (Recall #: Z-1430-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

SIGNA Premier magnetic resonance scanner, model 5748519.

Product Classification:

Class II

Date Initiated: June 24, 2022

Date Posted: July 27, 2022

Recall Number: Z-1430-2022

Event ID: 90587

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.

Status: Ongoing

Product Quantity: 52

Code Information:

SIGNA Premier GTINs: 00840682135269 and 00195278010797

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.

Voluntary or Mandated:

Voluntary: Firm initiated