Reported Oct 28, 2020 · Terminated
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic…
Invivo Corporation
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Invivo Corporation · 3545 SW 47th Ave · Gainesville, FL · 32608-7691
Is this the product you have?
- 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.
- Lot codes and dates
- Models
dS Knee Sch 3.0TdS Knee Sch 1.5TdS HiRes Hand/Wrist 16ch 1.5TdS HiRes Hand/WristdS Shoulder 16ch 3dS Shoulder 16ch 1.5TdS Shoulder Sch 1.STdS Shoulder Sch 3.0T
- Part Numbers
91 of 91 codes
4522-150-402024522-150-403624535-300-545814535-300-710714535-300-712714535-300-71281535-302-778614535-302-778714535-302-778914535-302-946114535-302-946124535-302-946134535-302-946214535-302-946234535-303-599314535-303-599514535-303-599534535-303-599714535-303-599734535-303-600314535-303-600334535-303-600514535-303-600534535-303-600714535-303-600734535-303-607514535-303-607714598-000-979744598-000-979844598-000-979944598-012-900414598-012-900424598-012-90051598-012-900614598-012-955314598-013-124114598-014-999514598-014-999714598-014-999914598-015-000314598-015-000514598-015-000719896-030-134329896-030-139729896-030-242829896-030-244024598-012-911314598-012-954819896-032-004419896-032-004429896-032-004439896-032-004519896-032-004539896-032-080119896-032-080219896-032-080319896-032-080519896-032-080619896-032-080719896-032-15621
- Serial Numbers
1,475 of 1,475 codes
52505468504745275528052445282549752535503525550512551655185256505105509527855085052553615532505455054352722020553050549531120195309505555055257865438532250589559154475587532750599559750591559853415809541354635061256295340541656165062653455348564854715360
- Models
- Amount recalled
- 12,764 units
Where it was sold
Why it was recalled
The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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