GE Medical Systems, LLC: Medical Device Recall in 2025 - (Recall #: Z-2130-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

SIGNA Architect

Product Classification:

Class II

Date Initiated: May 23, 2025

Date Posted: July 30, 2025

Recall Number: Z-2130-2025

Event ID: 97030

Reason for Recall:

GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

Status: Ongoing

Product Quantity: N/A

Code Information:

GTIN: 00840682147095 00840682122702 00195278023643 00840682123440

Distribution Pattern:

Worldwide distribution - US Nationwide and the country of China.

Voluntary or Mandated:

Voluntary: Firm initiated