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U.S. Department of Health and Human Services

Class 2 Device Recall HillRom Likorall 200

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  Class 2 Device Recall HillRom Likorall 200 see related information
Date Initiated by Firm August 09, 2016
Date Posted October 31, 2016
Recall Status1 Terminated 3 on March 24, 2017
Recall Number Z-0326-2017
Recall Event ID 75197
Product Classification Lift, patient, non-ac-powered - Product Code FSA
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.
Code Information manufacturing date between Dec 01, 2015- Apr 14, 2016
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
1069 State Road 46 E
Batesville IN 47006-7520
For Additional Information Contact Hill-Rom Technical Support
800-445-3720
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action On 8/9/2016, URGENT: MEDICAL DEVICE CORRECTION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any questions regarding this Field Safety Correction, please contact Hill-Rom Technical Support at 1-800-445-3720, your distributor or your Hill-Rom representative.
Quantity in Commerce 188
Distribution WA NC OH PA MI Australia Sweden
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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