Stryker recalls ENT software version NOVA 3.6.0 RC16 for visual feedback errors during sinus surgery. Affected units may show incorrect points relative to physical reference points.
Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction.
Stryker is recalling a specific version of ENT software (Scopis with TGS) that shows incorrect visual feedback during surgery. This could lead to inaccurate surgical planning if the software displays points that don't match the physical reference point of the surgical instruments.
The software shows points that are off from the physical reference point of the surgical instruments during endoscopic sinus surgery. This could cause inaccurate surgical planning if the surgeon relies on the visual feedback to guide their instruments.
Surgeons using the Stryker Scopis ENT Software version NOVA 3.6.0 RC16 for endoscopic sinus surgery. The risk is low as the software error is a visual display issue, not a physical hazard.
Check if your software version is NOVA 3.6.0 RC16 with product code 8000-021-002. The software is used with the Stryker Electromagnetic Navigation Unit (8000-010-003) for endoscopic sinus surgery.
Verify your software version is NOVA 3.6.0 RC16 with product code 8000-021-002.
The software shows visual feedback that may be off from the physical reference point, but it is a low-risk issue that does not cause physical harm.
Check if your software version is NOVA 3.6.0 RC16 with product code 8000-021-002, used with the Stryker Electromagnetic Navigation Unit (8000-010-003).
Check your software version. If it matches the recalled version, contact Stryker for guidance.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1885-2024 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1885-2024 from Stryker. 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.
