Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 31, 2018
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 SA…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Canon Medical System, USA, INC. recalled Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic ima… - a moderate-severity action.
Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic ima… was recalled by Canon Medical System, USA, INC. in October 31, 2018. Reason: When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specific Absorptio…. Check the official notice for the remedy. Verify recall #Z-0199-2019 with the FDA Devices before acting.
The recall
Canon Medical System, USA, INC. issued this moderate-severity FDA Devices recall-When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specific Absorptio….
- Moderate
- severity level
- 252 units
- affected scope
- Class II
- classification
- October 31, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0199-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0199-2019) was formally reported on October 31, 2018, with the manufacturer initiating the action on May 30, 2018. It is classified under Moderate severity (Class II), with a current status of Ongoing. Canon Medical System, USA, INC. is listed as the recalling firm, operating out of Tustin, CA. Federal records list the affected scope as 252.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: 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, Ban…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
252
Related Recalls
6
0 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0199-2019 |
| Date reported | October 31, 2018 |
| Date initiated | May 30, 2018 |
| Recalling firm | Canon Medical System, USA, INC. |
| Firm location | Tustin, CA |
| Affected scope | 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, Can… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0199-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Canon Medical System, USA, INC.. Units affected: 252.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 31, 2018. Severity: Moderate. Recall number: Z-0199-2019.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0199-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 31, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.