CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing softw
FDA device recall Z-2135-2024 · posted 2024-06-11 · Open, Classified
Recall details
- Recalling firm
- Blue Belt Technologies, Inc
- Reason for recall
- CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen of the CORI Surgical System during use, and may cause surgical delay
- Action taken
- Smith & Nephew (Blue Belt wholly owned subsidiary of Smith & Nephew, Inc.) issued Urgent Medical Device Correction Notice C-2024-03 notification on May 7, 2024. Letter states reason for recall, health risk and action to take: Required Actions for user/hospital: 1. Please see attached IFU Addendum for troubleshooting tips and notes to enhance the consistency of visibility of the markers and tracking arrays. This IFU Addendum can be found at https://ifu.smith-nephew.com/ by searching IFU number 1000264245. 2. Complete Correction Notice Acknowledgement Form and submit to FieldActions@smith-nephew.com. 3. A Smith & Nephew Robotics Representative will be deployed to your site to implement a new software version to correct the issue once it is available.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OLO
- Quantity affected
- 916 units
- Distribution
- Nationwide Foreign: Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Neth
- Date initiated
- 2024-05-07
- Date posted
- 2024-06-11
- Location
- Pittsburgh, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Real Intelligence™ CORI™ (K240139) | Blue Belt Technologies, Inc. | 2024-03-18 |