Z-1864-2012 Class II Terminated
FDA device recall Z-1864-2012 was initiated by Hill-Rom, Inc. on Jun 18, 2012 and is designated Class II. 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. The recall status is terminated (terminated Jun 6, 2014). Affected quantity: 7843 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 4, 2012
- Initiation Date
- Jun 18, 2012
- Termination Date
- Jun 6, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7843 devices
Product Description
Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.
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 Pattern
Worldwide Distribution-USA (nationwide) and the countries of Canada, France, and Singapore.
Code Information
AdvantaTM 2 beds (P1190) produced between August 10, 2009 and October 6, 2011; bed S/N between K222AT9180 and M279AT4403
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1864-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026