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.
Recall
- Recall Number
- Z-0199-2019
- Event Number
- 81026
- Firm
- Canon Medical System, USA, INC.
- FEI Number
- 2020563
- Product Code
- LNH
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- May 30, 2018
- Address
- 2441 Michelle Dr, Tustin, CA, 92780-7047
Description
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.
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.
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.
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