Invivo MR Coils Recalled for Incorrect IPX1 Water Ingress Rating Label
Invivo Corporation is recalling 12,764 MR Coils because the labels were mistakenly printed with an IPX1 rating symbol, which indicates water ingress protection.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding water ingress ratings, fitting the 'Low' severity criteria for documentation or packaging-only problems.
Plain-English summary
Invivo Corporation is recalling 12,764 units of MR Coils intended for use with Magnetic Resonance Scanners to produce diagnostic images. The recall is due to a labeling error where the product labels were mistakenly printed with an IPX1 rating symbol. IPX ratings relate to the protections products have from water ingress.
The affected products include various models such as dS Knee Sch 3.0T, dS HiRes Hand/Wrist 16ch 1.5T, and dS Shoulder 16ch 3.0T, among others. These units were distributed nationwide in the United States and to numerous countries internationally.
Consumers and healthcare facilities should check their inventory for the specific part numbers and serial numbers listed in the official recall notice. If the product is found, it should be removed from service and returned to Invivo Corporation or the original distributor for replacement or refund.
The recalled product
- Product
- MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
- Manufacturer
- Invivo Corporation
- Hazard
- Affected units
- 12,764
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Models: dS Knee Sch 3.0T
- dS Knee Sch 1.5T
- dS HiRes Hand/Wrist 16ch 1.5T
- dS HiRes Hand/Wrist
- dS Shoulder 16ch 3
- dS Shoulder 16ch 1.5T
- dS Shoulder Sch 1.ST
- dS Shoulder Sch 3.0T. Part Numbers: 4522-150-40202
- 4522-150-40362
- 4535-300-54581
- 4535-300-71071
- 4535-300-71271
- 4535-300-71281
- 535-302-77861
- 4535-302-77871
- 4535-302-77891
- 4535-302-94611
- 4535-302-94612
- 4535-302-94613
- 4535-302-94621
Distribution
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