Recall MonitorHealth Products
CareLink™ SmartSync™ Device Manager
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular, Health products - Medical devices - General hospital and personal use
Product: CareLink™ SmartSync™ Device Manager
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Patient Connector | More than 10 numbers, contact manufacturer. | 24967 |
| CareLink™ SmartSync™ 24970A | More than 10 numbers, contact manufacturer. | 24970A |
| CareLink™ SmartSync™ Common Application | More than 10 numbers, contact manufacturer. | M01A02 |
Issue
An update within the Apple iPad Operating System (OS) may reduce Bluetooth disconnections between the Medtronic CareLink™ SmartSync™ (SmartSync) device manager software and its associated accessories.Bluetooth disconnections occur for a variety of reasons. This Apple iPadOS update addresses specific disconnections due to data corruption between the iPad's Bluetooth controller and the SmartSync base station and/or patient connector.Bluetooth disconnections during a SmartSync patient session may lead to harm due to undesirable or incomplete parameter programming.