Device product
Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
Z-0983-2024
Product summary
- 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
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.