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U.S. Department of Health and Human Services

Class 2 Device Recall HS HiR NEO 900A NIR

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  Class 2 Device Recall HS HiR NEO 900A NIR see related information
Date Initiated by Firm July 31, 2019
Create Date September 05, 2019
Recall Status1 Terminated 3 on April 16, 2020
Recall Number Z-2484-2019
Recall Event ID 83571
Product Classification Microscope, surgical - Product Code EPT
Product HS Hi-R NEO 900A NIR
Reference # 657 822
Serial # from 101

Product Usage:
A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities.
Code Information The Error only occurs in combination with the following floor stands FS 2-21, FS 2-25, FS 3-45 with the software REF 615 586 in the versions 10.1.xx to 11.3.xx  1. Product: FS 2-21, Reference # 615 510 Serial # 101 to 360, SW-Version: 10.1.xx to 11.3.xx  2. Product: FS 2-21, Reference # 615 510, serial # from 361  3. Product: FS 2-25, Reference # 615 550, Serial # 101 to 376, SW Version: 10.1.xx to 11.3.xx  4. Product: FS 2-25, Reference # 615 550, Serial # from 377  4. Product: FS 3-45, Reference # 615 705, Serial #from 101
Recalling Firm/
Manufacturer		 Haag-Streit USA Inc
3535 Kings Mills Rd
Mason OH 45040-2303
For Additional Information Contact Jack Cummings
513-398-3937
Manufacturer Reason
for Recall		 software error in the central control unit of the floor stand.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action 1. Do not perform any other functions at the same time when operation the XY control, such as changes in the light intensity. 2. Perform a software update of the floor stand. you will receive the software version 11.4 through your local representative which will fix the bug. 3. please send us the enclosed response form filled In as soon as possible. 4. If you have passed the products to third parties, please forward a copy of this information and inform the below mentioned contact person. The software update will be organized through Haag-Streit USA. For questions concerning this procedure, please contact: Brian Gallagher Phone: (513) 486-1522 Email: fieldsafetynotice@haag-streit-usa .com
Quantity in Commerce 1
Distribution US in the state of OH
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.
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