Nuclear Magnetic Resonance Imaging Systems that are indicated for use… — Class II medical device recall Z-0199-2019
Ongoing recall by Canon Medical System, USA, INC., reported 2018-10-31, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specific Absorption
| Recall number | Z-0199-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canon Medical System, USA, INC., Tustin, CA, United States |
| Recall initiated | 2018-05-30 |
| Classified | 2018-10-22 |
| Reported by FDA | 2018-10-31 |
| Distributed | 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, WY |
| Countries outside the US | AE, AU, BD, BR, CA, CN, CO, DO, DZ, EG, HN, ID, IN, IR, JP, KE, KR, LB, MA, MX, MY, NG, NL, OM, PK, PY, QA, SA, SG, TH, TR, TW, VN, ZA |
| Quantity | 252 |
| Serial numbers | 292490, 298422, 299271, 299453, 299545, 30000547, 30001465, 30001882, 30002102, 30002103, 30002325, 30002625, 30002698, 30003156, 30003217, 30003291, 30004266, 30004544, 30004737, 30004842, 30004910, 30004937, 30005810, 30005914, 30005999 and 370 more |
| Model numbers | 30032698, 30035150, 30036289, 30040716, 70000226, MEXL-1510, MEXL-1510/S2, MEXL-1510/S2/E, MEXL-1510/S3, MEXL-1520, MEXL-1520/S1, S1B1492068, S1C1672334, S1C1682336, S1C1722390, S1D17Y2461, S2A1552005, S2A1562006, S2A1572008, S2A1582010, S2A1582012, S2A1592013, S2A15Y2016, S2A15Y2018, S2A15Y2019 and 55 more |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0199-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.