The Recall Desk
ModerateFDA (Devices)·Z-2482-2019·Announced 2019-09-11

Haag-Streit Recalls HS Hi-R NEO 900 Operating Microscopes Due to Software Error

Haag-Streit USA Inc is recalling HS Hi-R NEO 900 operating microscopes because a software error in the floor stand's central control unit may affect device function.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a software error in a medical device, which fits the criteria for a moderate severity recall where the risk is present but no adverse health consequences have been reported.

Plain-English summary

Haag-Streit USA Inc is recalling HS Hi-R NEO 900 operating microscopes, Reference # 657 820, Serial # from 101. The recall is due to a software error in the central control unit of the floor stand. The affected equipment includes specific floor stand models (FS 2-21, FS 2-25, and FS 3-45) used in combination with the operating microscopes.

The error occurs specifically when the floor stands are used with software REF 615 586 in versions 10.1.xx to 11.3.xx. The distribution pattern for this recall is limited to the United States, specifically the state of Ohio. The source text does not report any specific injuries, illnesses, or fatalities associated with this software error.

Healthcare facilities and users should identify if they possess the affected serial numbers and software versions. Users should contact the recalling firm, Haag-Streit USA Inc, for instructions on how to resolve the software error or obtain a replacement unit. The source text does not provide specific contact details or remediation steps beyond the recall notice itself.

The recalled product

Product
HS Hi-R NEO 900 Reference # 657 820 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 H
Manufacturer
Haag-Streit USA Inc
Category
Medical Device — Surgical Microscope
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • The Error only occurs in combination with the following floor stands FS 2-21
  • FS 2-25
  • 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
  • Serial # from 377 4. Product: FS 3-45
  • Reference # 615 705
  • Serial #from 101

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by Haag-Streit USA Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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