Z-1864-2012Class II

Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area...

Name: Z-1864-2012 Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area...
Creator: Hill-Rom, Inc.
Published: 2012-06-18
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2012-06-18 / Terminated / root cause: manufacturing process

FDA source

Hill-Rom, Inc. began a recall of Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital on 2012-06-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1864-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-18
Posted: 2012-06-22
Terminated: 2014-06-06
Recalling firm: Hill-Rom Inc.
Product: Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.
Product code: FNL Bed, Ac-Powered Adjustable 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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 7843 devices
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada, France, and Singapore.
Product codes and lots: AdvantaTM 2 beds (P1190) produced between August 10, 2009 and October 6, 2011; bed S/N between K222AT9180 and M279AT4403

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1864-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1864-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-22

Product code FNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)