Z-2484-2019Class II

HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101

Name: Z-2484-2019 HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101
Creator: Haag-Streit USA Inc
Published: 2019-07-31
License: https://open.fda.gov/license/

Haag-Streit USA Inc / initiated 2019-07-31 / Terminated / root cause: software

FDA source

Haag-Streit USA Inc began a recall of 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... on 2019-07-31. FDA classified it as Class II and gives the reason as "software error in the central control unit of the floor stand". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2484-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-31
Posted: 2019-09-05
Terminated: 2020-04-16
Recalling firm: Haag-Streit USA Inc
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.
Product code: EPT Microscope, Surgical
Reason for recall: software error in the central control unit of the floor stand.
Root cause tag: software
FDA 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 in commerce: 1
Distribution: US in the state of OH
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2484-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2482-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-05
Z-2483-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-05
Z-2484-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-05

Product code EPT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)