510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0274-2016Class II

Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed

Hill-Rom Inc. / initiated 2015-10-07 / Terminated / root cause: design

Hill-Rom, Inc. began a recall of Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0274-2016
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
Product
Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed
Product code
FNL Bed, Ac-Powered Adjustable Hospital
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.
Root cause tag
design
FDA root cause
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.
Product codes and lots
Product # P3930A; Dates of Manufacture 5-DEC-2007 to 14-SEP-2015; Serial numbers from I325AR0038 thru Q257AR2299

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0274-2016
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0274-2016Class IITerminatedVoluntary: Firm initiated