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.
The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress.
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.
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.
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.
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.
Inspect the coil labels for the incorrect IPX1 water rating symbol. No action is required as the coils are safe to use.
No, the recall does not require stopping use. The labels are incorrect but the coils function normally.
No action is needed. The recall is for labeling correction only, not a safety hazard.
Yes, the MR Coils are safe to use. The recall addresses a labeling error, not a safety issue.
We’ve drafted a message you can send Invivo to request your refund or repair — edit it as you like.
Subject: Recall Z-0126-2021 — Invivo Invivo Hello, I own a Invivo that is covered by recall Z-0126-2021 from Invivo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
