Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.
This recall has been terminated (originally issued June 22, 2012).
- Company
- Hill-Rom, Inc.
- Recall Initiated
- June 18, 2012
- Posted
- June 22, 2012
- Terminated
- June 6, 2014
- Recall Number
- Z-1864-2012
- Quantity
- 7843 devices
- Firm Location
- Batesville, IN
- Official Source
- View on FDA website ↗
Reason for Recall
During an evaluation of Advanta 2 siderail samples returned from the field it was found that the screws used to attach the siderail were being stripped from the plastic cavity of the siderail.
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Canada, France, and Singapore.
Lot / Code Info
AdvantaTM 2 beds (P1190) produced between August 10, 2009 and October 6, 2011; bed S/N between K222AT9180 and M279AT4403
Root Cause
Process design
Action Taken
Hill-Rom sent an "URGENT FIELD SAFETY NOTICE" dated May 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included a Customer Response Form for customers to complete and return to the firm. Contact Hill-Rom Technical Support at 800-445-3720 for questions regarding this notice.