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Terminated

IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2

FDA Recall Z-0683-2016 · Posted 2016-01-21

Recalling FirmIba Dosimetry Gmbh
Recall StatusTerminated
Product CodeIYE
Date Initiated2015-12-10
Date Terminated2018-08-08

Reason for Recall

When the electric lift table is connected to the mains power, in a very rare occasion, the table may start to move up in an uncontrolled manner.

Firm Action

The field safety notice including a confirmation of receipt was sent to the affected hospitals; by email on 12/10/2015 then followed by 12/17/2015 sent by Fed Ex. The firm requested the mains power be disconnected after setting up the table and BP. Replacement part and instructions will follow.

Root Cause

Component design/selection

Distribution Pattern

Nationwide and International: Algeria, Angola, Arab Republic of Egypt, Austria, Belarus, Belgium, Bulgaria, Bosnia and Herzegovina, Croatia, Czech Republic, Denmark, Ethiopia, France, Germany, Ghana, Greece, Hungary, Iraq, Ireland, Islamic Republic Iran, Italy, Kazakhstan, Kenya, Kingdom of Saudi Arabia, Kuwait, Lebanon, Libya, Morocco

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K945321WELLHOFER WP700 V. 3.2Medical Physics Instrumentation, Inc. · 1995-07-12

Official Source

View FDA Recall →

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

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