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 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.

Recall number

Z-2483-2019

Recalling firm

Haag-Streit USA Inc

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 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.

Status

Terminated

Initiated

2019-07-31

Posted

not on file

Terminated

2020-04-16

Reason

software error in the central control unit of the floor stand.

Root cause

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

0

Distribution

US in the state of OH

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

EPT

Firm FEI

1000136533

Firm city

Mason

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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