Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1319-2018Class II

Progressa Bed - AC-powered adjustable hospital bed

Hill-Rom Inc. / initiated 2018-01-12 / Terminated

Hill-Rom, Inc. began a recall of Progressa Bed - AC-powered adjustable hospital bed on . FDA classified it as Class II and gives the reason as "A component used within the braking system may break resulting in one or more brake pedals on the bed staying in brake or not being engaged which could result in unwanted bed movement and possible patient or user injury". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1319-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
Product
Progressa Bed - AC-powered adjustable hospital bed
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall
A component used within the braking system may break resulting in one or more brake pedals on the bed staying in brake or not being engaged which could result in unwanted bed movement and possible patient or user injury.
FDA root cause
Component change control
Action
Firm has developed a correction for the braking system and plan to have a Hill-Rom technician to update affected Progressa Beds. Hill-Rom sent a letter, dated January 12, 2018. Until beds are updated, follow the safety information as outlined in the Progressa User manual each time when setting the brakes. Warning: Always set the brakes when the bed is occupied, except during patient transport. To help make sure the bed will not move, push and pull on the bed to check it after the brakes are engaged. Brakes should always be set when the bed is occupied and especially when moving a patient from one surface to another. Patients often use the bed for support when getting out of bed and could be injured if the bed unexpectedly moves. After setting the brakes, push and pull the bed to make sure of stability. If the brakes do not hold after following the instructions above, take the bed out of service until the bed is updated.
Quantity in commerce
2117
Distribution
Worldwide distribution. US nationwide, Canada, Chile, Colombia, Costa Rica, France, Hong Kong, Israel, Jamaica, Japan, Jordan, Malaysia, Mexico, Oman, Panama, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, UAE, and UK.
Product codes and lots
S159AW9192 through S305AW2321 Beds manufactured from June 8, 2017 to November 1, 2017

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1319-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1319-2018Class IITerminatedVoluntary: Firm initiated