{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "184345", "product_res_number": "Z-0697-2021", "event_date_initiated": "2020-11-20", "event_date_created": "2020-12-23", "recall_status": "Open, Classified", "res_event_number": "86707", "product_code": "HRM", "product_description": "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_info": "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) \tHS Hi-R NEO 900 +EMWM657 820 0/$+serial no. \tHS Hi-R NEO 900A +EMWM657 821 0/$+serial no. \tFS 2 11 +EMWM 615H5110/$+serial no. \tFS 2-15 +EMWM 615H515 0/$+serial no.", "firm_fei_number": "1000136533", "recalling_firm": "Haag-Streit USA Inc", "address_1": "3535 Kings Mills Rd", "city": "Mason", "state": "OH", "postal_code": "45040-2303", "additional_info_contact": "Brian Gallagher\n513-486-1522", "reason_for_recall": "Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by\npressing 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", "root_cause_description": "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:\nSince the error only occurs when using the optional microscope accessory EIBOS 2, we recommend the following\naction:\n1. Operate the focusing only as described in the instructions for use 668 600 part 5.4 when the fundus\nobservation module EIBOS 2 is swiveled in (see following extract from the above-mentioned Instructions for Use).\n5.4 During Surgery\nSurgery starts at the anterior segment of the eye.\nThe operating microscope is focused on the cornea or the iris.\nThe EIBOS 2 is folded upwards.\n\" Fold the EIBOS 2 down to observe the posterior segment of the eye.\n\" Focus the EIBOS 2 exclusively via its operating elements for focusing.\nDo not use the focusing of the operating microscope.\n\" Use the foot switch to position the EIBOS 2 by means of the XV-coupling over the patient's eye.\n\" Fold the EIBOS 2 up to observe the anterior segment of the eye\n\n2. If the error occurs, press the focus button on the footswitch again. By pressing once more, the software error\nis corrected and the focusing works normally again. It is not possible for the error to occur twice in a row.\nAttention: 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.\n3. 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.\n4. Please send us the enclosed Acknowledgement Letter filled in as soon as the software update is complete.\nTransmission of the information Please ensure that all users of the products mentioned are aware of and receive this urgent safety information. If\nyou have passed the products to third parties, please forward them a c", "product_quantity": "3 units US", "distribution_pattern": "US Nationwide distribution in the state of OK.", "openfda": { "k_number": [ "K852150", "K891001", "K914956", "K852586", "K891584", "K844323", "K920641", "K932720", "K930439", "K854440", "K850270", "K853855", "K792083", "K822563" ], "registration_number": [ "9612297", "3005216736", "3038356864", "3007532396", "3003969012", "3014865", "3021343245", "2028159", "9617248", "3007143236", "3013576617", "3010183984", "1000176188", "3002808383", "3038287496", "9710516", "9710018", "2521877", "3024078476", "1048735", "3011898560", "3027667933", "3010774780", "9710098", "3009560832", "3010208880", "3011215096", "3003553186", "1037885", "3030516433", "3006252153", "9615010", "3021656770", "1211998", "1018470", "9614661", "3016017660", "9615030", "9611269", "3003974370", "3002562003", "3013403214", "3003588303", "8030607", "3009746052", "3008729548", "1836161", "3032734659", "2242863", "3031700059", "3006946276", "3003623887", "1000204638", "3005527296", "2031962", "8020986", "3015531959", "3005755367", "9610810" ], "fei_number": [ "3005216736", "3014865", "3038356864", "3007532396", "3003969012", "3021343245", "3002807375", "3007143236", "3006509795", "3013576617", "1000176188", "3002808383", "3002750084", "3038287496", "2521877", "3024078476", "1048735", "3011898560", "3027667933", "3010774780", "3009560832", "3010208880", "1000125771", "3011215096", "3003553186", "1037885", "3030516433", "3002807782", "3003481798", "3006252153", "3001362763", "3021656770", "1211998", "1018470", "3016017660", "3003340745", "3003974370", "3002562003", "3013403214", "3001802794", "3003588303", "3009746052", "4196", "3005435924", "3008729548", "3002809378", "3032734659", "2242863", "3031700059", "3006946276", "3003623887", "1000204638", "1000175127", "3005527296", "3002957101", "3015531959", "3002445546", "3005755367", "3011022890" ], "device_name": "Microscope, Operating & Accessories, Ac-Powered, Ophthalmic", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4700", "device_class": "1" } } ] }