Reported Jul 31, 2024 · Ongoing
NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions
Medtronic Xomed, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Medtronic Xomed, Inc. · 6743 Southpoint Dr N · Jacksonville, FL · 32216-6218
Is this the product you have?
NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions
5 of 5 products
| Model / number | Product as published |
|---|---|
NIM4CM01. | CONSOLE NIM4CM01 NIM 4.0 |
NIM4CM01RF | CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED |
NIM4CPB1 | PATIENT INTERFACE NIM4CPB1 NIM 4.0 |
NIM4CPB1RF | PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB |
NIM4SWU143 | SOFTWARE NIM4SWU143 UPGRADE V1.4.3 |
- Lot codes and dates
- All serial numbers manufactured)
- with NIM Vital System versions
v1.0.0v1.1.1v1.3.2v1.4.3. Product Number
- GTIN Number (Lot Number)1
- Product NumberNIM4CM01
- GTIN Number (Lot Number)
3,137 of 3,137 codes
00763000002978 (185007618500791850082185008318500931850095C1915008C1915009C1915012C1915013C1915014C1915015C1915018C1915020C1915022C1915025C1915027C1915028C1915030C1915031C1915032C1915038C1915039C1915040C1915042C1915048C1915053C1915057C1915061C1915062C1915063C1915064C1915065C1915066C1915068C1915069C1915070C1915072C1915073C1915074C1915075C1915077C1915080C1915085C1915089C1915090C1915094C1915096C1915098C1915102C1915103C1915104C1915105C1915106C1915107C1915108C1915109C1915110C1915116C1915119
- Product NumberNIM4CM01RF
- GTIN Number00763000002992 (Lot
- Numbers
C1915118C1915120C1915126C2026347C2026475C2110088C2110098C2110122C2110160C2110164C2110178C2110277C2110322C2110355C2110373C2148047C2148073C2148079C2148181C2148207C2148401C2148414C2148459C2148460C2214049C2214147C2214252C2214319C2250089C2250166C2250221C2250278C2250280C2250281C2250418C2250426C2314116C2314366C2322054C2322055C2322056C2322177). 3
- Product NumberNIM4CPB1
- GTIN Numbers (Lot Numbers)
00763000002985 (2008141P1910178P1910180P1910181P1910188P1910192P1910193P1910196P1910197P1910203P1910204P1910205P1910207P1910208P1910209P1910210P1910211P1910228P1910232P1910254P1910270P1910274P1910275P1910277P1910278P1910279P1910280P1910281P1910282P1910283P1910284P1910290P1910301P1910304P1910305P1910309P1910311P1910314P1910317P1910326P19
- Amount recalled
- 7,804 units
Where it was sold
Why it was recalled
Stop using this product now
Potential for false negative response on the NIM Vital Nerve Monitoring System
Using this product could cause serious injury, illness or death — stop using it now.
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