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Recall Observatory FDA recall evidence

Device product

Progressa Bed - AC-powered adjustable hospital bed

Z-1319-2018

January 12, 2018

Class II

Product summary

Firm
Hill-Rom, Inc.
Event
Event 79516
Status
Terminated
Classification
Class II
Quantity
2117
Official record key
device-enforcement:Z-1319-2018

Official wording

Reason: 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.

Code information: S159AW9192 through S305AW2321 Beds manufactured from June 8, 2017 to November 1, 2017

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.