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Signa™ architect
Official notice
7 Nov 2024
Last checked
7 Nov 2024
An official Health Canada notice concerns Signa™ architect. 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 Published 2024-11-07.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76461
Official notice
2024-11-07
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
Recall Numbers
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Turn on automatic VIN checksAffected products
Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand
Manufacturer
Phone
Brand: GE Medical, Signa™ Architect.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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