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Recall Observatory FDA recall evidence

Device product

Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.

Z-0326-2017

August 09, 2016

Class II

Product summary

Firm
Hill-Rom, Inc.
Event
Event 75197
Status
Terminated
Classification
Class II
Quantity
188
Official record key
device-enforcement:Z-0326-2017

Official wording

Reason: Ceiling Bracket 71 was shipped with a larger center hole. A potentially hazardous situation exists that if the Ceiling Bracket 71 with a larger center hole is used for a concrete ceiling Ultra System installation with the M8 screw and the safe working load is exceeded, the system could fall.

Code information: manufacturing date between Dec 01, 2015- Apr 14, 2016

Distribution pattern: WA NC OH PA MI Australia Sweden

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Ceiling Bracket 71 was shipped with a larger center hole. A potentially hazardous situation exists that if the Ceiling Bracket 71 with a larger center hole is used for a concrete ceiling Ultra System installation with the M8 screw and the safe working load is exceeded, the system could fall.