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Terminated

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,

FDA Recall Z-1249-06 · Posted 2006-07-22

Recalling FirmHamilton Medical Inc
Recall StatusTerminated
Product CodeCBK
Date Initiated2006-05-24
Date Terminated2006-12-21
Product Quantity2,385 for all models

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052863RAPHAEL COLORHamilton Medical AG · 2006-01-06K022679RAPHAELHamilton Medical AG · 2003-10-22

Official Source

View FDA Recall →

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

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