Hill-Rom Basic Care Bed, P1441A (Non-electric), Hill Rom Batesville, IN. Intended for low to moderate acuity patients in

FDA device recall Z-2170-2010 · posted 2010-08-03 · Terminated

Recall details

Recalling firm

Hill-Rom, Inc.

Reason for recall

The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the pivot pin E-ring, which could cause the E-ring to come off.

Action taken

The firm sent an Urgent Field Safety Notice to its customers dated 9/16/2009. The letter identified the affected product, explained the reason for the recall, actions to be taken, and a contact reference. Customers are to locate the affected product, examine the pivot points and ensure the E-ring is present. If the E-ring is missing, then the affected bed is to be taken out of service. Customers' distributors or agents will contact them with a permanent fix. Questions should be directed towards Hill-Rom Technical Support.

Root cause

Device Design

Status

Terminated

Product code

FNJ

Quantity affected

962 beds

Distribution

Worldwide Distribution -- Argentina, Bahrain, Bhutan, Brazil, Bulgaria, Chili, China, Columbia, Costa Rica, Ecuador, Egypt, Eritrea, France, Hong Kong, India, Indonesia, Iran, Iraq, Jordan, Kenya, Kuw

Date initiated

2009-09-16

Date posted

2010-08-03

Date terminated

2012-03-16

Location

Batesville, IN