Reported Oct 31, 2018 · Ongoing
Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces…
Canon Medical System, USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Canon Medical System, USA, INC. · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body.
- Lot codes and dates
- MODEL SERIAL NUMBER SIDModel
586 of 586 codes
MEXL-1504/U4U4A12Z202030005914MEXL-1504/T4S4D1132069339325MEXL-1504/S4S4A1032017326165MEXL-1504/U4U4A131202330000547MEXL-1504/S4S4A1032019327601MEXL-1504/U4U4A131202430002325MEXL-1504/T4S4D1152082330035MEXL-1504/S4S4A1082040330134MEXL-1504/A4A4A11Z2011346866MEXL-1504/U4U4A1282003356105MEXL-1504/U4U4A132202530009003MEXL-1504/U4U4B144207030012516MEXL-1504/U4U4A1352035389636MEXL-1504/U4U4B155209730010318MEXL-1504/U4U4A12X2010351817MEXL-1504/S4S4C1112065330381MEXL-1504/S4S4C1112064334599MEXL-1504/A4A4A11Z2009352039MEXL-1504/S4.004S4A107203330025756MEXL-1504/S4S4A09Y2002345231
Model129 of 129 codes
MEXL-1510MEXL-1510/S2S2B1642037MEXL-1510/S2S2A15Y2019MEXL-1510/S2/ES2B16Y2055MEXL-1510/S2S2B1652041MEXL-1510/S2S2C1762072MEXL-1510/S3S3A16Z2007MEXL-1510/S2/ES2C1772077MEXL-1510/S2S2A1592013MEXL-1510/S3S3B1782012MEXL-1510/S2S2A1612025MEXL-1510/S2/ES2B1692050MEXL-1510/S3S3A1692003MEXL-1510/S2/ES2C1772075MEXL-1510/S3S3B17Y2016MEXL-1510/S2S2A15Z2023MEXL-1510/S2S2A15Y2018MEXL-1510/S2/ES2C1772074MEXL-1510/S2S2C1782081MEXL-1510/S3S3B1762010MEXL-1510/S2S2C1762071MEXL-1510/S3S3B1762009MEXL-1510/S2S2C1782082MEXL-1510/S2S2B1632035MEXL-1510/S2/ES2D1812097MEXL-1510/S2S2A1582010MEXL-1510/S2/ES2B16Z2061MEXL-1510/S2/ES2B1732065MEXL-1510/S2S2B1632036MEXL-1510/S2S2B1672045MEXL-1510/S3
MEXL-1520MEXL-1520/S1S1C167233430032698MEXL-1520/S1S1C168233630035150MEXL-1520/S1S1C172239030040716MEXL-1520/S1S1D17Y246130036289MEXL-1520/S1S1B149206870000226
- MODEL SERIAL NUMBER SID
- Amount recalled
- 252
Where it was sold
Why it was recalled
When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specific Absorption Rate) value displayed on the console may be lower than the actual SAR value. The actual applied SAR values may exceed the FIRST LEVEL CONTROLLED OPERATING MODE.
This product could cause temporary or reversible health problems — stop using it.
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