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U.S. Department of Health and Human Services

Class 2 Device Recall HillRom 100 Low Bed (GPAC)

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  Class 2 Device Recall HillRom 100 Low Bed (GPAC) see related information
Date Initiated by Firm October 07, 2015
Date Posted November 13, 2015
Recall Status1 Terminated 3 on February 10, 2017
Recall Number Z-0274-2016
Recall Event ID 72423
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
Product Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed
Code Information Product # P3930A; Dates of Manufacture 5-DEC-2007 to 14-SEP-2015; Serial numbers from I325AR0038 thru Q257AR2299
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
1069 State Road 46 E
Batesville IN 47006-7520
For Additional Information Contact Karla Fields
812-934-7777
Manufacturer Reason
for Recall		 Hill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints of patient injury when exiting the beds set at the lowest position setting.
FDA Determined
Cause 2		 Device Design
Action Hill-Rom initiated Phase 1 of the recall on October 2, 2015, which included notices of the recall being issued to customers via certified mail, which included safety information on how to properly use the bed, and instructions to forward the information on if devices have been transferred. Phase 2 for the recall will include the distribution of caps for the edges of the bed to be placed on by the customers. Customers may contact Hill-Rom Technical Support at 800-445-3720.
Quantity in Commerce 12251 units
Distribution Worldwide Distribution - USA (nationwide) to the states of : AL, AR, AZ. CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV., and to the countries of : Canada and France.
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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