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Terminated

Hill-Rom 100 Low Bed, Model P3930. AC-powered adjustable hospital bed.

FDA Recall Z-0338-2010 · Posted 2009-11-18

Recalling FirmHill-Rom, Inc.
Recall StatusTerminated
Product CodeFNL
Date Initiated2009-04-20
Date Terminated2010-10-15
Product Quantity4017 beds

Reason for Recall

The siderails may exhibit false latching, or unintentional lowering, or may become inoperable.

Firm Action

Hill Rom notified consignees by recall letter dated 4/20/09 and advised them of the problem and requested them to locate the beds. Consignees with patients in need of siderails were directed to be moved to a different model bed with siderails and, if the patient did not need siderails; consignees were requested to remove the siderails, move the siderails to a stowed position, to tie the siderail to the bed frame or to tag the siderail as out of service. The letter stated the consignee would be contacted within 90 days by a firm representative to do a correction on all affected units.

Root Cause

Process control

Distribution Pattern

Worldwide distribution: USA, Canada, France, India, Singapore and Spain.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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