Recall Z-0199-2019 ยท LNH System, Nuclear Magnetic Resonance Imaging
Canon Medical System, USA, INC.
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.
| Date | May 30, 2018 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| 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 sca |
| Quantity | 252 |
| Distribution | 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, |
| FDA record | Open on fda.gov |