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Terminated

CLINITRON UP-LIFT Air Fluidized Therapy unit.

FDA Recall Z-0990-03 · Posted 2003-07-10

Recalling FirmHill-Rom Manufacturing, Inc.
Recall StatusTerminated
Product CodeINX
Date Initiated2003-05-05
Date Terminated2004-07-26
Product Quantity122 units (including both units)

Reason for Recall

Malfunction of side-rail latching pin coupled with inadequate directions for use.

Firm Action

Consignees were notified by letter sent via Airborne express, on May 5, 2003. Side-rail latching pins will be replaced with a more robust version. Label indicating directions for use will be modified to include detailed information on proper procedures for moving the units.

Root Cause

Other

Distribution Pattern

The units are primarily leased to hospitals. Units have been sold to hospitals located nationwide and to Canada, Austria, France, Germany Ireland Italy, Netherlands, Spain, Sweden, Switzerland and the United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K920112CLINITRON C-IISupport Systems Intl. · 1992-01-24

Official Source

View FDA Recall →

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

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