Haag-Streit recalls specific models of surgical microscopes with software errors that may cause incorrect surgical measurements during procedures. Affected units include certain FS 2-21, FS 2-25, and FS 3-45 floor stands with specific serial numbers and software versions.
software error in the central control unit of the floor stand.
Haag-Streit is recalling specific models of surgical microscopes that have a software error in the central control unit. This error could lead to incorrect surgical measurements during procedures, which might affect patient safety.
The software error in the central control unit can cause incorrect surgical measurements when used with specific floor stands (FS 2-21, FS 2-25, FS 3-45) and software versions 10.1.xx to 11.3.xx. This may lead to unintended surgical outcomes if the error affects critical measurements during procedures.
Surgical professionals using Haag-Streit HS Hi-R NEO 900A NIR microscopes with specific floor stands and software versions are most at risk. Patients undergoing procedures with these affected devices may experience inaccurate measurements.
Check if your microscope has the model HS Hi-R NEO 900A NIR with the floor stand model FS 2-21, FS 2-25, or FS 3-45. Look for serial numbers and software versions listed in the recall notice: serial numbers from 101 to 360 or 361, and software versions 10.1.xx to 11.3.xx.
Verify your microscope's software version by checking the device settings or documentation. The affected versions are 10.1.xx to 11.3.xx.
Reach out to Haag-Streit USA Inc for guidance on whether your specific unit is affected and what steps to take next.
The recall affects Haag-Streit HS Hi-R NEO 900A NIR microscopes paired with specific floor stands: FS 2-21, FS 2-25, or FS 3-45, with serial numbers and software versions as listed in the recall notice.
The recall notice does not specify a fix or remedy for the software error. Affected users should contact Haag-Streit USA Inc for further instructions.
Check your microscope's serial number and software version. Affected units have serial numbers from 101 to 360 or 361 for FS 2-21, and specific ranges for FS 2-25 and FS 3-45, with software versions 10.1.xx to 11.3.xx.
We’ve drafted a message you can send Haag-Streit to request your refund or repair — edit it as you like.
Subject: Recall Z-2484-2019 — Haag-Streit Haag-Streit Hello, I own a Haag-Streit that is covered by recall Z-2484-2019 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.
