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 SID

    586 of 586 codes

    • MEXL-1504/U4
    • U4A12Z2020
    • 30005914
    • MEXL-1504/T4
    • S4D1132069
    • 339325
    • MEXL-1504/S4
    • S4A1032017
    • 326165
    • MEXL-1504/U4
    • U4A1312023
    • 30000547
    • MEXL-1504/S4
    • S4A1032019
    • 327601
    • MEXL-1504/U4
    • U4A1312024
    • 30002325
    • MEXL-1504/T4
    • S4D1152082
    • 330035
    • MEXL-1504/S4
    • S4A1082040
    • 330134
    • MEXL-1504/A4
    • A4A11Z2011
    • 346866
    • MEXL-1504/U4
    • U4A1282003
    • 356105
    • MEXL-1504/U4
    • U4A1322025
    • 30009003
    • MEXL-1504/U4
    • U4B1442070
    • 30012516
    • MEXL-1504/U4
    • U4A1352035
    • 389636
    • MEXL-1504/U4
    • U4B1552097
    • 30010318
    • MEXL-1504/U4
    • U4A12X2010
    • 351817
    • MEXL-1504/S4
    • S4C1112065
    • 330381
    • MEXL-1504/S4
    • S4C1112064
    • 334599
    • MEXL-1504/A4
    • A4A11Z2009
    • 352039
    • MEXL-1504/S4.004
    • S4A1072033
    • 30025756
    • MEXL-1504/S4
    • S4A09Y2002
    • 345231
    Model

    129 of 129 codes

    • MEXL-1510
    • MEXL-1510/S2
    • S2B1642037
    • MEXL-1510/S2
    • S2A15Y2019
    • MEXL-1510/S2/E
    • S2B16Y2055
    • MEXL-1510/S2
    • S2B1652041
    • MEXL-1510/S2
    • S2C1762072
    • MEXL-1510/S3
    • S3A16Z2007
    • MEXL-1510/S2/E
    • S2C1772077
    • MEXL-1510/S2
    • S2A1592013
    • MEXL-1510/S3
    • S3B1782012
    • MEXL-1510/S2
    • S2A1612025
    • MEXL-1510/S2/E
    • S2B1692050
    • MEXL-1510/S3
    • S3A1692003
    • MEXL-1510/S2/E
    • S2C1772075
    • MEXL-1510/S3
    • S3B17Y2016
    • MEXL-1510/S2
    • S2A15Z2023
    • MEXL-1510/S2
    • S2A15Y2018
    • MEXL-1510/S2/E
    • S2C1772074
    • MEXL-1510/S2
    • S2C1782081
    • MEXL-1510/S3
    • S3B1762010
    • MEXL-1510/S2
    • S2C1762071
    • MEXL-1510/S3
    • S3B1762009
    • MEXL-1510/S2
    • S2C1782082
    • MEXL-1510/S2
    • S2B1632035
    • MEXL-1510/S2/E
    • S2D1812097
    • MEXL-1510/S2
    • S2A1582010
    • MEXL-1510/S2/E
    • S2B16Z2061
    • MEXL-1510/S2/E
    • S2B1732065
    • MEXL-1510/S2
    • S2B1632036
    • MEXL-1510/S2
    • S2B1672045
    • MEXL-1510/S3
    Model
    • MEXL-1520
    • MEXL-1520/S1
    • S1C1672334
    • 30032698
    • MEXL-1520/S1
    • S1C1682336
    • 30035150
    • MEXL-1520/S1
    • S1C1722390
    • 30040716
    • MEXL-1520/S1
    • S1D17Y2461
    • 30036289
    • MEXL-1520/S1
    • S1B1492068
    • 70000226
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.

Want the full recall guide?

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.