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Synchromed ii - programmable pump

Official notice

5 Dec 2023

Last checked

5 Dec 2023

Medium riskHealth Canada

An official Health Canada notice concerns Synchromed ii - programmable pump. Medtronic recently identified that if the Synchromed II Pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field. In this case, drug delivery will only resume after performing a post MRI pump interrogation with the clinician programmer which will end telemetry mode. Recall Start Date: November 21, 2023 Published 2023-12-05.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74681

Official notice

2023-12-05

The hazard

Medtronic recently identified that if the Synchromed II Pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field. In this case, drug delivery will only resume after performing a post MRI pump interrogation with the clinician programmer which will end telemetry mode. Recall Start Date: November 21, 2023

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.

Recall Numbers

74681

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Affected products

Product 1

Affected products - Synchromed II - Programmable Pump, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 8637-20 8637-40

Risk / hazard

Medtronic recently identified that if the Synchromed II Pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field. In this case, drug delivery will only resume after performing a post MRI pump interrogation with the clinician programmer which will end telemetry mode. Recall Start Date: November 21, 2023

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Medtronic, Synchromed Ii - Programmable Pump.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74681

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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