Blue Belt Technologies, Inc: Device Recall
Recall #Z-2135-2024 · 05/07/2024
Recall Details
- Recall Number
- Z-2135-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Blue Belt Technologies, Inc
- Status
- Ongoing
- Date Initiated
- 05/07/2024
- Location
- Pittsburgh, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 916 units
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
Product Description
CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000 CORI Starter Kit (2) ROB10024 Real Intelligence CORI (3) ROB10197 CORI STARTER KIT - UNIVERSAL Note: the three product numbers cover the three different configurations in which the CORI Console is sold
Distribution Pattern
Nationwide Foreign: Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, UK