Haag-Streit recalls surgical floor stands FS 2-11 and FS 2-15 with specific software versions that may cause eye injury during use in ophthalmology. Affected units have serial numbers starting from 1001.
Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye
Haag-Streit is recalling surgical floor stands FS 2-11 and FS 2-15 that come with certain software versions. These stands could potentially cause eye injury to patients if the focusing mechanism doesn't stop when the button is released during surgery.
The software error causes the focusing mechanism to continue moving after the button is released. This could lead to unintended movement of the surgical instrument, potentially causing injury to the patient's eye during delicate eye surgery procedures.
Surgical teams using Haag-Streit floor stands with specific software versions (2.0 to 3.3) in ophthalmology procedures are most at risk. Patients undergoing eye surgery with these stands could face injury if the focusing mechanism malfunctions.
Check if your Haag-Streit surgical floor stand has serial numbers starting from 1001. The affected models are FS 2-11 (Ref 615H511) and FS 2-15 (Ref 615H515) with software versions 2.0 to 3.3. Also check the unique device identifier codes on the product.
Verify the software version on your Haag-Streit surgical floor stand. If it is 2.0 to 3.3, it is affected.
Reach out to Haag-Streit USA Inc for guidance on next steps and potential remedies.
The software error could cause the focusing mechanism to continue moving after the button is released, potentially injuring the patient's eye. Affected units should be checked for the specific software versions.
Software REF 615 588 versions 2.0 to 3.3 are affected.
Check if your Haag-Streit FS 2-11 (serial numbers starting from 1001) or FS 2-15 (serial numbers starting from 1001) has software versions 2.0 to 3.3.
We’ve drafted a message you can send Haag-Streit to request your refund or repair — edit it as you like.
Subject: Recall Z-0697-2021 — Haag-Streit Haag-Streit Hello, I own a Haag-Streit that is covered by recall Z-0697-2021 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.
