Invivo MR Coils Recall: Incorrect Water Rating Labels May Cause Damage
Invivo Corporation recalls MR Coils with mistakenly printed IPX1 water rating labels. These coils are used with MRI scanners. Affected models include dS Knee Sch 1.5T, dS Shoulder Sch 3.0T, and others. No action is required as the labels are incorrect but not dangerous.
Lower-risk recall
The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress.
Contact the company
What happened, in plain English
Invivo Corporation is recalling certain MR Coils used with MRI scanners because the labels mistakenly show an IPX1 water rating. This incorrect rating could lead to confusion about water resistance, but the coils themselves are not damaged and no action is needed. Read more at govinfonow.com/recall/64287-invivo-mr-coils-recall-incorrect-water-rating-labels-may-cause.
Source Summary by GovInfoNow · govinfonow.com/recall/64287-invivo-mr-coils-recall-incorrect-water-rating-labels-may-cause · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0126-2021
Cite this page
“Invivo MR Coils Recall: Incorrect Water Rating Labels May Cause Damage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64287-invivo-mr-coils-recall-incorrect-water-rating-labels-may-cause. Based on FDA recall #Z-0126-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0126-2021%22&limit=1).
Why it’s dangerous
The labels on the MR Coils have been printed with an IPX1 rating symbol, which indicates water resistance. However, this rating is incorrect and could cause confusion about whether the coils are water-resistant. The hazard is minor and does not affect the coil's safety or function.
Who’s affected
Medical professionals who use Invivo MR Coils with MRI scanners may own or use these products. The risk is low as the labels are incorrect but the coils function normally.
How to tell if you have this one
Check for MR Coils with models listed: dS Knee Sch 1.5T, dS Knee Sch 3.0T, dS Shoulder Sch 1.5T, dS Shoulder Sch 3.0T, and others. Look for the specific part numbers and serial numbers listed in the recall notice.
- Brand
Invivo- Category
Medical device
What to do — step by step
Check Labels
Inspect the coil labels for the incorrect IPX1 water rating symbol. No action is required as the coils are safe to use.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 39 states.
FDA distribution: “US Nationwide Distribution: AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OK, OH, PA, PR, RI, SC, TN, TX, VA, VT, WA, WI, and WV; and the countries of: Albania, Algeria,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Are these MR Coils safe to use?
Yes, the MR Coils are safe to use. The recall addresses a labeling error, not a safety issue.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0126-2021 (September 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0126-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.