510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
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Z-1466-2013Class II

Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for low to moderate acuity patient in...

Hill-Rom Inc. / initiated 2013-04-15 / Terminated / root cause: manufacturing process

Hill-Rom, Inc. began a recall of 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 on . FDA classified it as Class II and gives the reason as "Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to the frame". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1466-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
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.
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall
Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to the frame.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
On 4/16/2013 an URGENT MEDICAL DEVICE CORRECTION notification letter was sent to all consignees. The firm plans a visit to all facilities to correct each bed. Call Hill-Rom Technical Support at 800-445-3720 if you have any questions.
Quantity in commerce
8,737 devices
Distribution
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.
Product codes and lots
Product number (P1160) with Serial Numbers J143AP0937 thru O080AP5661.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1466-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1466-2013Class IITerminatedVoluntary: Firm initiated