FDA recall Z-0983-2024

Steris Corporation · Class II · device

Product

Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754

Reason for recall

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.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2023-12-12
Report date
2024-02-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mentor, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0983-2024