Z-2593-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 8, 2018
- Initiation Date
- June 29, 2018
- Termination Date
- February 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 units
Product Description
MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.
Reason for Recall
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Distribution Pattern
Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV; and to countries of:: Australia, Canada, China, Dominican Republic, Hong Kong, India, Japan, Korea, Malaysia, Mexico, Pakistan, Panama, Peru, Singapore, Sri Lanka, Taiwan, and Thailand.
Code Information
69626; 78445; 81360; 1526205; 1560439; 1610839; 1527910; 1560448; 1621857; 1959100; 2012964