Recall Z-0199-2019— Canon Medical System, USA, INC.
Class II · Ongoing
Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2018-05-30. It names 3 FDA 510(k) clearances: K171597, K170412, K120638. Product: 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.. 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..
- Recalling firm
- Canon Medical System, USA, INC.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-05-30
- Firm location
- Tustin, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K171597 — Vantage Elan 1.5T, V4.0
- K170412 — Vantage Titan 1.5T, MRT-1510, M-Power GX
- K120638 — VANTAGE TITAN
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.