Z-1318-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 18, 2018
- Initiation Date
- December 6, 2017
- Termination Date
- May 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 933 ( of which 97 has been quarantined)
Product Description
Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of this medical device, as part of system to store and position ophthalmological examination and diagnostic equipment, is to store and position for examination a device commonly known as a refractor.
Reason for Recall
Product has been found with a missing Washer, Retaining Ring, and/or Stop Screw. Recalling firm was notified by distributor that Refractor Suspension Arm fell on a patient s lower torso along with the arm housing
Distribution Pattern
Worldwide Distribution - USA(nationwide) Distribution to the states of : NJ, CA, OH, VA, MA, MN, IL , UT, TN, AR, LA, AZ, PA, TX, IA and HI., and to the countries of : Costa Rica, Jamaica, South Africa, New Zealand, South Korea, Dubai, Saudi Arabia and Jordan.
Code Information
Model Number: 525004, 05 and 525006, 07