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U.S. Department of Health and Human Services

Class 2 Device Recall Haag Streit Surgical Floor stands

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  Class 2 Device Recall Haag Streit Surgical Floor stands see related information
Date Initiated by Firm November 20, 2020
Create Date December 23, 2020
Recall Status1 Open3, Classified
Recall Number Z-0697-2021
Recall Event ID 86707
Product Classification Microscope, operating & accessories, ac-powered, ophthalmic - Product Code HRM
Product Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in ophthalmology and in other disciplines with vertical direction of view
Code Information Floor stands FS 2-11, FS 2-15 with the software REF 615 588 in versions 2.0 to 3.3.   FS 2-11 Ref. # 615H511 Serial Numbers:From 1001; FS 2-15 Ref. #615H515 Serial Numbers From 1001; HS Hi-R NEO 900 Ref. # 657 Serial Numbers 820 from 101; HS Hi-R NEO 900A Ref # 657 821 Serial Numbers from 101   Unique Device Identifier (UDI)  HS Hi-R NEO 900 +EMWM657 820 0/$+serial no.  HS Hi-R NEO 900A +EMWM657 821 0/$+serial no.  FS 2 11 +EMWM 615H5110/$+serial no.  FS 2-15 +EMWM 615H515 0/$+serial no.  
Recalling Firm/
Manufacturer		 Haag-Streit USA Inc
3535 Kings Mills Rd
Mason OH 45040-2303
For Additional Information Contact Brian Gallagher
513-486-1522
Manufacturer Reason
for Recall		 Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye
FDA Determined
Cause 2		 Software design
Action Haag-Streit USA, Inc. notified accounts by Urgent Medical Device Correction letter via UPS on 11/20 and delivered 11/24, stating reason for recall, health risk, and action to take: Since the error only occurs when using the optional microscope accessory EIBOS 2, we recommend the following action: 1. Operate the focusing only as described in the instructions for use 668 600 part 5.4 when the fundus observation module EIBOS 2 is swiveled in (see following extract from the above-mentioned Instructions for Use). 5.4 During Surgery Surgery starts at the anterior segment of the eye. The operating microscope is focused on the cornea or the iris. The EIBOS 2 is folded upwards. " Fold the EIBOS 2 down to observe the posterior segment of the eye. " Focus the EIBOS 2 exclusively via its operating elements for focusing. Do not use the focusing of the operating microscope. " Use the foot switch to position the EIBOS 2 by means of the XV-coupling over the patient's eye. " Fold the EIBOS 2 up to observe the anterior segment of the eye 2. If the error occurs, press the focus button on the footswitch again. By pressing once more, the software error is corrected and the focusing works normally again. It is not possible for the error to occur twice in a row. Attention: After 10 seconds of focusing, during which the microscope moves in the direction of the patient's eye, the EIBOS 2 spring suspension to protect the eye is at the end position and the EIBOS 2 is pressed into the eye. 3. Perform a software update of the floor stand. You will receive the software version 3.4 through your local Haag-Streit USA representative who will fix the error. 4. Please send us the enclosed Acknowledgement Letter filled in as soon as the software update is complete. Transmission of the information Please ensure that all users of the products mentioned are aware of and receive this urgent safety information. If you have passed the products to third parties, please forward them a c
Quantity in Commerce 3 units US
Distribution US Nationwide distribution in the state of OK.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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