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

FDA device recall Z-0274-2016 · posted 2015-11-13 · Terminated

Recall details

Recalling firm

Hill-Rom, Inc.

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

FNL

Quantity affected

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,

Date initiated

2015-10-07

Date posted

2015-11-13

Date terminated

2017-02-10

Location

Batesville, IN