Recall Z-1466-2013
Hill-Rom, Inc. · initiated April 15, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Product number (P1160) with Serial Numbers J143AP0937 thru O080AP5661.
Reason for recall
Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to the frame.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1466-2013
- Initiated
- April 15, 2013
- Posted by FDA
- June 5, 2013
- Terminated
- February 7, 2017
- Product code
- FNL – Bed, Ac-Powered Adjustable Hospital
- Quantity
- 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…
- Recalling firm
- Hill-Rom, Inc., Batesville, IN