The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1864-2012·Announced 2012-07-04

Hill-Rom Recalls Advanta 2 Hospital Beds Due to Siderail Screw Stripping

Hill-Rom is recalling 7,843 Advanta 2 hospital beds because screws used to attach siderails were found to be stripping from the plastic cavity.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect in a medical device (siderail screw stripping) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Hill-Rom, Inc. is recalling 7,843 units of the Advanta 2 Bed, a medical device intended for low to moderate acuity patients in the medical/surgical area of the hospital. The recall involves Advanta 2 beds (P1190) produced between August 10, 2009, and October 6, 2011, with serial numbers between K222AT9180 and M279AT4403.

The recall was initiated after an evaluation of Advanta 2 siderail samples returned from the field revealed that the screws used to attach the siderail were being stripped from the plastic cavity of the siderail. This defect could potentially compromise the structural integrity of the siderail attachment.

The affected devices were distributed nationwide in the United States, as well as in Canada, France, and Singapore. No specific instructions for consumers or healthcare facilities are provided in the source text, but the recall is classified as Class II by the FDA.

The recalled product

Product
Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.
Manufacturer
Hill-Rom, Inc.
Category
Medical Device — Hospital Bed
Hazard
Affected units
7,843

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • AdvantaTM 2 beds (P1190) produced between August 10
  • 2009 and October 6
  • 2011
  • bed S/N between K222AT9180 and M279AT4403

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Hill-Rom, Inc.

See all →

Same hazard · structural defect

See all →

Similar recalls