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U.S. Department of Health and Human Services

Class 2 Device Recall Progressa Bed

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  Class 2 Device Recall Progressa Bed see related information
Date Initiated by Firm January 12, 2018
Create Date April 09, 2018
Recall Status1 Terminated 3 on June 26, 2020
Recall Number Z-1319-2018
Recall Event ID 79516
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
Product Progressa Bed - AC-powered adjustable hospital bed
Code Information S159AW9192 through S305AW2321 Beds manufactured from June 8, 2017 to November 1, 2017
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
1069 State Road 46 E
Batesville IN 47006-7520
For Additional Information Contact Brian Crosley
812-934-7777
Manufacturer 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 Determined
Cause 2		 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.
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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