# FDA recall Z-0199-2019

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2018-05-30.

## 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 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.

## 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, 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

## Key facts

- **Recall number:** Z-0199-2019
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-05-30
- **Report date:** 2018-10-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tustin, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0199-2019

## Citation

> AI Analytics. FDA recall Z-0199-2019. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0199-2019. Source: US FDA. Licensed CC0.

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