Scopis ENT Navigation Software Contains Visual Guidance Alignment Error
Unreleased software in Scopis ENT surgical navigation systems causes visual guidance to display inaccurately relative to physical reference points, affecting surgical precision. Affects 705 units nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Class II FDA classification with no reported injuries or illnesses. This is a risk-of-harm product where a software defect directly affects surgical navigation accuracy, meeting the High criteria despite absence of reported adverse events.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling 705 units of Scopis ENT Software with TGS (Software Version NOVA 3.6.0 RC16), a surgical navigation system used in functional endoscopic sinus surgery (FESS).
The affected units contain unreleased software that causes the visual guidance displayed on the system screen to show inaccurate positioning relative to the physical reference point of the surgical pointer or suction instrument. This misalignment between visual and physical references could impact surgical precision during navigation.
The recall affects systems distributed nationwide across the United States. Affected units are identified by serial numbers listed in the recall documentation.
Healthcare facilities using affected Scopis systems should contact Stryker Leibinger for software updates or replacement instructions to ensure accurate surgical guidance during FESS procedures.
The recalled product
- Product
- 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system.…
- Manufacturer
- Stryker Leibinger GmbH & Co. KG
- Affected units
- 705
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 (20)
- Sofware Version: NOVA 3.6.0 RC16
- Product Code: 8000-021-002
- UDI/DI: 07613327514179
- Serial Numbers: 10984
- 10110
- 10164
- 10454
- 10762
- 10387
- 10120
- 10252
- 10414
- 10612
- 10408
- 10673
- 11013
- 11032
- 10566
- 10974
- 0310-B
Distribution
Distributed nationwide across the United States.
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