The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2484-2019·Announced 2019-09-11

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

Haag-Streit USA Inc is recalling HS Hi-R NEO 900A operating microscopes and specific floor stands due to a software error in the central control unit.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 injuries, illnesses, or deaths. The hazard is a software error without reported harm, fitting the criteria for a moderate severity score.

Plain-English summary

Haag-Streit USA Inc is recalling the HS Hi-R NEO 900A NIR operating microscope (Reference # 657 822, Serial # from 101) and specific floor stands (FS 2-21, FS 2-25, and FS 3-45) due to a software error in the central control unit of the floor stand. The affected floor stands are identified by specific reference numbers and serial number ranges, and the error occurs in combination with software versions 10.1.xx to 11.3.xx.

The recall is limited to units distributed in the state of Ohio. The source text does not report any injuries, illnesses, or deaths associated with this software error. Consumers and healthcare facilities should contact the recalling firm for instructions on how to resolve the software issue.

The recalled product

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…
Manufacturer
Haag-Streit USA Inc
Category
Medical Device — Surgical Microscope
Hazard
Affected units
1

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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