FDA Recall Terminated

Hill-Rom 305 Bed, P1441B - Non electric, Hill Rom Batesville, IN. Intended for low to moderate acuity patients in the low end acute care area of the hospital.

Recall: Z-2167-2010 · Initiated September 16, 2009

Recall

Recall Number
Z-2167-2010
Event Number
56018
Firm
Hill-Rom, Inc. 125 E Pearl St 1069 State Route 46 East Batesville IN 47006
FEI Number
1824206
Product Code
FNJ
Status
Terminated
Root Cause
Device Design
Initiated
September 16, 2009
Posted
August 3, 2010
Terminated
March 16, 2012

Description

Hill-Rom 305 Bed, P1441B - Non electric, Hill Rom Batesville, IN. Intended for low to moderate acuity patients in the low end acute care area of the hospital.

Reason

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

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.

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, Kuwait, Lebanon, Libya, Malaysia, Mexico, Morocco, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Syria, Taiwan, Thailand, Trinidad & Tobago, Turkey, United Arab Emirates, United States, Uruguay, Venezuela, and Vietnam.

Quantity

2,586 beds