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Recall Observatory FDA recall evidence

Device product

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.

Z-1318-2018

December 06, 2017

Class II

Product summary

Firm
Reliance Medical Products Inc
Event
Event 79601
Status
Terminated
Classification
Class II
Quantity
933 ( of which 97 has been quarantined)
Official record key
device-enforcement:Z-1318-2018

Official wording

Reason: 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

Code information: Model Number: 525004, 05 and 525006, 07

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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