RecallDepth

Hamilton brand RAPHAEL Ventilator (Software Versio 2.2x), Product is distributed by Hamilton Medical, Inc., 4990 Energy Way,Reno, NV 89502-Serial Numbers 2975 to 5360,

Company
Hamilton Medical Inc
Recall Initiated
May 24, 2006
Posted
July 22, 2006
Terminated
December 21, 2006
Recall Number
Z-1249-06
Quantity
2,385 for all models
Firm Location
Reno, NV

Reason for Recall

ALARM FAILURE-Following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system.

Distribution

Worldwide

Lot / Code Info

Serial Numbers 2975 to 5360

Root Cause

Other

Action Taken

On May 24, 2006 the manufacturer initiated this recall. The Recalling establishment/US Initial Importer/Distributor-received the manufacturer''s notice on May 31, 2006 and initiated their recall on June 1, 2006. The US distributor has issued a Medical Device Field Correction.

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