Recall Monitor
Health Products

SPECTRALIS® with Flex Module

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Ophthalmology
Product: SPECTRALIS® with Flex Module
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
SPECTRALIS® with Flex ModuleSpec-21986S2610
SPECTRALIS® with Flex ModuleSpec-24546S3610
SPECTRALIS® with Flex ModuleSpec-23776S3610
SPECTRALIS® with Flex ModuleSpec-13403S3610
SPECTRALIS® with Flex ModuleSpec-15400S3610

Issue

There is a possibility that the castor wheels of the Flex stand are not properly attached. The wheels may come loose. As a result, the Flex stand may tip over. Users shall schedule a service appointment as soon as possible so that the castor fastenings can be inspected and corrected.

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