Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for low to moderate acuity patient in...
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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1466-2013 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
