SIGNA™ Architect
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
SIGNA™ Architect |
905684MR3T |
SIGNA ARCHITECT |
Issue
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 may 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. Prolonged periods of exposure to elevated acoustic noise could potentially lead to hearing impairment.
Recall start date: October 31, 2024
Additional information
Details
| Ge Medical Systems Llc |
| 3200 North Grandview Blvd, Waukesha, Wisconsin, United States, 53188 |
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