Class 2 Device Recall DualArticulating Headrest

• Date Initiated by Firm: December 12, 2023
• Date Posted: February 05, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0984-2024
• Recall Event ID: 93733
• Product Classification: Headrest, neurosurgical - Product Code HBM
• Product: Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
• Code Information: UDI-DI: 00724995195885, date of manufacture 2023-08-14 thru 2023-10-26.
• FEI Number: 1527821
• Recalling Firm/ Manufacturer: Steris Corporation; 5960 Heisley Rd; Mentor OH 44060-1834
• For Additional Information Contact: Michelle LaVan; 440-392-8603
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: An Urgent Medical Device Recall notice dated December 5, 2023 was issued to distributors and customers via FedEx explaining the removal of specific affected product . The notice explains the labeled date of manufacture must fall between August 14, 2023 and October 26, 2023 the recall notice must have been received directly from STERIS. The 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. STERIS Service Technician will work with your facility to schedule a time to hand-deliver replacement head rest(s) and pick up your affected head rest(s). It is recommended all head rests impacted by this recall be immediately removed from service until it can be replaced. If you have further distributed this product, please identify all locations, notify them of this recall, and coordinate the collection of all affected head rest(s).
• Quantity in Commerce: 80
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.