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Recall Observatory FDA recall evidence

Device product

Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for low to moderate acuity patient in the medical surgical area of the hospital.

Z-1466-2013

April 15, 2013

Class II

Product summary

Firm
Hill-Rom, Inc.
Event
Event 65257
Status
Terminated
Classification
Class II
Quantity
8,737 devices
Official record key
device-enforcement:Z-1466-2013

Official wording

Reason: Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to the frame.

Code information: Product number (P1160) with Serial Numbers J143AP0937 thru O080AP5661.

Distribution pattern: Worldwide distribution: US (Nationwide) and countries of: Argentina , Bahamas, Bahrain, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, Ethiopia, France, Ghana, Guam, Hong Kong, India, Indonesia, Japan, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, N. Mariana Islands, Pakistan, panama, Paraguay, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates, United States, US Virgin Islands, Venezuela and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to the frame.