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Open, Classified

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.

FDA Recall Z-0199-2019 · Posted None

Recalling FirmCanon Medical System, USA, INC.
Recall StatusOpen, Classified
Product CodeLNH
Date Initiated2018-05-30
Product Quantity252

Reason for Recall

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.

Firm Action

On 05/20/2018 the firm sent an Urgent Medical Device Correction letter to customers via United States Postal Service return receipt mail informing them that when a user used the respiratory gating with Steady Mode ON in Spin Echo sequence scan, the SAR value displayed on console was lower than the actual SAR value because there was a wrong estimating the RF pulses in the software. The SAR may exceed the upper limit, when a user scans a patient near the upper limit of the first level controlled operating mode in case of using the respiratory gating with Steady Mode ON in Spin Echo sequence scan. That may cause a burn of a patient. Applicable System/Model: -MEXL-1504/MEXL-1510: Vantage Titan -MEXL-1520: Vantage Elan Corrective Action: Modified system software to correct this issue will be installed on your system. When the software becomes available, your Canon service representative will contact your for an appointment to schedule the installation. Request to Customers: Until the modification is completed on your system, do not use Spin Echo sequences when using respiratory gating with Steady Mode ON. If you wish to use respiratory gating with Steady Mode ON, use Fast Spin Echo sequences. Please share this information with all users and reviewing radiologists as well as the clinical engineering or biomedical group at your facility. Customers are instructed to please complete the attached form and fax it to the toll-free number shown at the top of the form. This form can also be sent via email to [email protected]. If you have any questions, please feel free to contact Regulatory Affairs at (800) 421-1968 or your local service representative at (800) 521-1968.

Root Cause

Device Design

Distribution Pattern

Domestic: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, WA, WI, WV, and WY. International: Algeria, Australia, Bangladesh, Brazil, Canada, China, Colombia, Congo, Dominican Republic, Egypt, Guinea, Honduras, India, Indonesia, Iran, Japan, Kenya, Korea, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Nigeria, Oman, Pakistan, Paraguay, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, Turkey, UAE, and Vietnam

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K171597Vantage Elan 1.5T, V4.0Toshibamedical Systems Corporation · 2017-07-21K170412Vantage Titan 1.5T, MRT-1510, M-Power GXToshibamedical Systems Corporation · 2017-06-07K120638VANTAGE TITANToshibamedical Systems Corporation · 2012-06-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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