| Class 2 Device Recall HillRom 100 Low Bed (GPAC) | |
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
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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
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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 |
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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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