Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0983-2024

December 12, 2023

Class II

Product summary

Firm
Steris Corporation
Event
Event 93733
Status
Ongoing
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-0983-2024

Official wording

Reason: 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.

Code information: UDI-DI: 00724995197643, date of manufacture 2023-08-14 thru 2023-10-26.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.