Haag-Streit USA Inc HS Hi-R NEO 900A Reference # 657 821 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 Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
HS Hi-R NEO 900A Reference # 657 821 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
Brand
Haag-Streit USA Inc
Lot Codes / Batch Numbers
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
Products Sold
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
Haag-Streit USA Inc is recalling HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical due to software error in the central control unit of the floor stand.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
software error in the central control unit of the floor stand.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, OH
Page updated: Jan 10, 2026