Official recall record
SIGNA Architect
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-05-23
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00840682147095
- Brand on record
- GE Medical Systems, LLC
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2024-10-28 · US FDA — Medical Devices
SIGNA Architect, Nuclear Magnetic Resonance Imaging System
Other recalls from this brand
- 2026-06-05 · US FDA — Medical Devices
Optima XR200amx, Mobile Digital-Ready Radiographic System - 2026-06-05 · US FDA — Medical Devices
Optima XR240amx, Mobile Digital Radiographic System - 2026-06-05 · US FDA — Medical Devices
Optima XR220amx, Mobile Digital-Ready Radiographic System
All 62 official recall notices naming GE Medical Systems, LLC on this site →