The Recall Desk
HighFDA (Devices)·Z-2483-2019·Announced 2019-09-11

Haag-Streit Operating Microscope Floor Stand Software Error Recall

Haag-Streit USA Inc is recalling specific operating microscope floor stands due to a software error in the central control unit.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a software error that could impact surgical interventions, but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Haag-Streit USA Inc is recalling the HS Hi-R NEO 900A operating microscope floor stands (Reference # 657 821, Serial # from 101) and associated floor stands (FS 2-21, FS 2-25, and FS 3-45) due to a software error in the central control unit. The recall is limited to units distributed in Ohio, USA.

The error occurs specifically when the affected floor stands are used with software REF 615 586 in versions 10.1.xx to 11.3.xx. The source text does not report any injuries, illnesses, or deaths associated with this defect.

Healthcare facilities and users should identify if they possess the affected serial numbers and software versions. The source text does not provide specific consumer instructions or corrective actions beyond the identification of the defect.

The recalled product

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 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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