Recall Z-1885-2024 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
Stryker Leibinger GmbH & Co. KG
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. The Stryker Electromagnetic Navigation Unit (8000-010-003) powered by Scopis ENT Software with TGS (8000-021-002), allows t
| Date | May 23, 2024 (initiated Apr 4, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | On April 22, 2024 an URGENT MEDICAL DEVICE FIELD ACTION letters were sent to customers. Next Steps: 1. Locate any ENU. Quarantine and discontinue use until software on device has been confirmed. - Locate software version and serial number (see pg. 2 for instructions). - Your Stryker Sales Representatives may help, if needed. 2. Return the enclosed Business Reply Form (BRF) via email to instruments.recalls@stryker.com. - If Scopis ENT Software with TGS version NOVA 3.6.0 RC16 is installed, Stryker will arrange shipment of compliant software. 3. Once compliant software is received and installed |
| Quantity | 705 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit Stryker Corporation, Jul 12, 2022 |