Public recall detail

SPECTRALIS® with Flex Module

2026-08-19

medium
Health products Health product recall
Quick summary

Quick summary: SPECTRALIS® with Flex Module. Reason: Health product recall. Category: Health products. Date: 2026-08-19.

Recommended action

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

Recall details

Quick summary: SPECTRALIS® with Flex Module. Reason: Health product recall. Category: Health products. Date: 2026-08-19.

Official details

Affected product details

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

BrandHeidelberg Engineering GmbH
ProductSPECTRALIS® with Flex Module
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82505

Affected products

ProductSPECTRALIS® with Flex Module
LotSpec-21986
ModelS2610
Serial numberSpec-21986
DescriptionSPECTRALIS® with Flex Module
ProductSPECTRALIS® with Flex Module
LotSpec-24546
ModelS3610
Serial numberSpec-24546
DescriptionSPECTRALIS® with Flex Module
ProductSPECTRALIS® with Flex Module
LotSpec-23776
ModelS3610
Serial numberSpec-23776
DescriptionSPECTRALIS® with Flex Module
ProductSPECTRALIS® with Flex Module
LotSpec-13403
ModelS3610
Serial numberSpec-13403
DescriptionSPECTRALIS® with Flex Module
ProductSPECTRALIS® with Flex Module
LotSpec-15400
ModelS3610
Serial numberSpec-15400
DescriptionSPECTRALIS® with Flex Module

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Ophthalmology
CompaniesHeidelberg Engineering GmbH Max-Jarecki-Strasse 8, Heidelberg, Germany, 69115
Recall date2026-08-07
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82505
Background{}
CompaniesHeidelberg Engineering GmbH Max-Jarecki-Strasse 8, Heidelberg, Germany, 69115
AudiencesHealthcare
Source updated2026-08-19

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

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