Haag-Streit recalls specific models of HS Hi-R NEO 900A floor stands with software errors that could cause instability during surgery. Affected units must be checked for matching serial numbers and software versions.
software error in the central control unit of the floor stand.
Haag-Streit is recalling certain HS Hi-R NEO 900A floor stands due to a software error in the central control unit. This could cause instability during surgical procedures, potentially leading to injury if the equipment tips over.
The software error in the central control unit can cause the floor stand to become unstable during use. This instability might lead to the equipment tipping over, which could result in injury to the surgical team or patient.
Surgical professionals using Haag-Streit HS Hi-R NEO 900A floor stands with specific serial numbers and software versions are most at risk. The recall affects medical facilities that use these devices for ophthalmology and other specialized surgeries.
Check if your floor stand has the model FS 2-21, FS 2-25, or FS 3-45 with specific serial numbers and software versions listed in the recall notice. The affected units have reference numbers and serial numbers starting from 101.
Identify if your floor stand matches the model and serial number ranges specified in the recall notice.
Reach out to Haag-Streit for guidance on whether your unit is affected and what steps to take next.
Haag-Streit identified a software error in the central control unit of specific floor stands that could cause instability during surgical procedures.
Software versions 10.1.xx to 11.3.xx are affected, specifically with reference numbers 615 510, 615 550, and 615 705.
No, but you should check if your unit is affected and contact Haag-Streit for further instructions.
We’ve drafted a message you can send Haag-Streit to request your refund or repair — edit it as you like.
Subject: Recall Z-2483-2019 — Haag-Streit Haag-Streit Hello, I own a Haag-Streit that is covered by recall Z-2483-2019 from Haag-Streit. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.