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Vercise genus r16 and r32 ipg kits
Official notice
25 Apr 2024
An official Health Canada notice concerns Vercise genus r16 and r32 ipg kits. Boston Scientific has received reports of undesired sensation and/or transient worsening of movement disorder symptoms secondary to a transient loss of stimulation during IPG charging for patients with rechargeable DBS IPGs. Investigation of these reports determined that the device may reset (by design) due to detection of noise or interference during IPG charging. Recall Start Date: April 18, 2024 Published 2024-04-25.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75445
Official notice
2024-04-25
The hazard
The hazard
Boston Scientific has received reports of undesired sensation and/or transient worsening of movement disorder symptoms secondary to a transient loss of stimulation during IPG charging for patients with rechargeable DBS IPGs. Investigation of these reports determined that the device may reset (by design) due to detection of noise or interference during IPG charging. Recall Start Date: April 18, 2024
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Product 2
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Boston Scientific Neuromodulation, Vercise Genus R16 And R32 Ipg Kits.
Source & status
Source & status
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Category
Classification
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Recall details
Recall details
Recall number
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Source tier
Documents, notices & source
See the official notice and source documents for full details.
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