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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1319-2018 | Class II | Terminated | Voluntary: Firm initiated |
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