Hill-Rom 405 Bed, P1440B, (electric) Hill Rom Batesville, IN. Intended for low to moderate acuity patients in the low end acute care area of the hospital.
FDA Recall Z-2168-2010 · Posted 2010-08-03
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Recalling FirmHill-Rom, Inc.
Recall StatusTerminated
Product CodeFNL
Date Initiated2009-09-16
Date Terminated2012-03-16
Product Quantity2,973 beds
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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