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U.S. Department of Health and Human Services

Class 2 Device Recall SPECTRALIS

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  Class 2 Device Recall SPECTRALIS see related information
Date Initiated by Firm July 03, 2019
Create Date August 30, 2019
Recall Status1 Terminated 3 on November 02, 2020
Recall Number Z-2437-2019
Recall Event ID 83568
510(K)Number K181594  
Product Classification Tomography, optical coherence - Product Code OBO
Product SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Code Information All software versions with HEYEX2 image management system  Identification: TFID-3439 
Recalling Firm/
Manufacturer		 Heidelberg Engineering GmbH
Tiergartenstr. 15
Heidelberg Germany
Manufacturer Reason
for Recall		 Error in the default configuration which could lead to the incorrect display of patient master data.
FDA Determined
Cause 2		 Under Investigation by firm
Action Firm sent field safety notice 7/3/2019. Additionally the customer was asked to let a service technician access their software system to configure it in a way that the software error does not lead to further problems. 1. Do not drag-and-drop patient data onto the automatically created worklist partner as described above. 2. Do not execute a query or retrieve data using the automatically created worklist partner. 3. Always check whether displayed patient master data match the selected patient. In the event that displayed patient master data do not belong to the selected patient, do not create any new reports or screen shots of data for the affected patient. In this case, check already exported reports of this patient and correct the data manually or discard them if necessary. 4. A service technician will contact you to correct the configuration. This configuration correction will be performed remotely via a simple update. At the same time, the technician will also confirm the integrity of your database, ensuring that it is free of inconsistencies. If you have any question or concern, please contact FSCA-US@HeidelbergEngineering.com.
Quantity in Commerce 29
Distribution US nationwide distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OBO and Original Applicant = Heidelberg Engineering GmbH
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