Public recall detail

Invisus SLP Ultrasound Option

2022-10-13

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Recall Safety notice
Quick summary

Quick summary: Invisus SLP Ultrasound Option. Date: 2022-10-13.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Invisus SLP Ultrasound Option. Date: 2022-10-13.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandNatus Manufacturing Limited
ProductInvisus SLP Ultrasound Option
IssueMedical devices - Unauthorised device
Recall classType II
IdentificationRA-72018

Affected products

ProductInvisus SLP Ultrasound Option
LotNot applicable
ModelNot applicable
Serial numberNot applicable
DescriptionInvisus SLP Ultrasound Option

Issue

It has been identified that the Invisus SLP Ultrasound product is not registered to be sold in Canada, as there is no Canadian license for this part. Natus is not able to sell the Invisus SLP Ultrasound product into Canada and as part of this field corrective action Natus is required to rectify any product that has been incorrectly sold into the Canadian market by requesting a return and providing a refund. Recall start date: September 9, 2022

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesNatus Manufacturing Limited Ida Business Park, Gort, Galway, Ireland,
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-72018
Background{}
CompaniesNatus Manufacturing Limited Ida Business Park, Gort, Galway, Ireland,
AudiencesHealthcare
Source updated2022-10-13

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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