8000-021-002, Scopis ENT Software with TGS with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution f
FDA device recall Z-1885-2024 · posted 2024-05-23 · Open, Classified
Recall details
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Reason for recall
- 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.
- Action taken
- 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, return the enclosed Software Update Form via email to instruments.recalls@stryker.com to confirm completion of the recall action steps. 4. Maintain this notification internally until all required actions have been completed. Please contact Lacey Marshall at 269-270-5950 or Instruments.recalls@stryker.com with questions or concerns. Report any serious adverse events or product quality problems to Stryker Instruments: 1-800-253-3210. Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, or by fax or phone. Online: ww.fda.gov/Safety/MedWatch/HowToReport/default.htm Fax: (800) FDA-0178 Phone: (800) FDA-1088.
- Root cause
- Software Manufacturing/Software Deployment
- Status
- Open, Classified
- Product code
- PGW
- Quantity affected
- 705 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-04-04
- Date posted
- 2024-05-23
- Location
- Freiburg Im Breisgau, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit (K221098) | Stryker Corporation | 2022-07-12 |