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Proclaim and infinity implantable pulse generators
Official notice
15 Aug 2023
Last checked
15 Aug 2023
An official Health Canada notice concerns Proclaim and infinity implantable pulse generators. Abbott has received complaints from patients who are unable to exit MRI mode, as their patient controller has lost the ability to connect or communicate with their IPG while in MRI mode. Abbott sent a customer communication on 2023-07-21 to remind health care providers about use of the magnetic resonance imaging (MRI) mode feature on these systems and the associated risks related to inability to exit MRI mode, including the potential need for additional surgery to restore therapy. Recall start date: July 21, 2023 Published 2023-08-15.
What to do now
Contact the manufacturer if you require additional information.
Recall number
74120
Official notice
2023-08-15
The hazard
The hazard
Abbott has received complaints from patients who are unable to exit MRI mode, as their patient controller has lost the ability to connect or communicate with their IPG while in MRI mode. Abbott sent a customer communication on 2023-07-21 to remind health care providers about use of the magnetic resonance imaging (MRI) mode feature on these systems and the associated risks related to inability to exit MRI mode, including the potential need for additional surgery to restore therapy. Recall start date: July 21, 2023
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
Recall Numbers
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand
Manufacturer
Phone
Brand: Abbott Medical, Proclaim And Infinity Implantable Pulse Generators.
Source & status
Source & status
Source
Tier
Category
Classification
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Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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