FDA-Device2024-02-14Class II

Dual Articulating Headrest, Velcro P/N P141210813, REF BF753

Steris Corporation
Hazard

Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.

Sold states
Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN, IA, KS, LA, MN, MS, NV, NJ, OH, OK, OR, PA, TN, TX, UT, WA, WI & Puerto Rico, and the countries of Australia, Canada, Mexico & New Zealand.
Affected count
80
Manufactured in
5960 Heisley Rd, Mentor, OH, United States
Products
Dual Articulating Headrest, Velcro P/N P141210813, REF BF753

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0984-2024

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