MR System Gradient Coils May Exceed Acoustic Noise Safety Limits
GE HealthCare is recalling SIGNA Architect MR system gradient coils that can produce acoustic noise exceeding 99dB during scanning, potentially surpassing international safety limits even with required hearing protection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves a risk-of-harm product with potential for hearing damage from occupational acoustic noise exposure. The acoustic levels can exceed established international safety standards (IEC 60601-2-33). However, no injuries have been reported, and the hazard is theoretical, limiting the score to 3 (High) per the rubric.
Plain-English summary
GE HealthCare has identified that gradient coils used in SIGNA Architect MR systems can produce elevated acoustic noise during scanning. Under specific conditions, acoustic levels can exceed 99dB, surpassing the limit established by International Electrotechnical Commission standard IEC 60601-2-33 even when operators use hearing protection with a Noise Reduction Rating of 29dB as specified in the current Operator Manual.
The affected product is distributed worldwide, including throughout the United States and China. Healthcare facilities operating SIGNA Architect MR systems should ensure they are following all hearing protection requirements in the Operator Manual and contact GE Medical Systems, LLC for additional guidance.
The recalled product
- Product
- SIGNA Architect
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- acoustic-noise
- hearing-damage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 00840682147095 00840682122702 00195278023643 00840682123440
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03