Hamilton brand RAPHAEL Color Ventilator (Software Vesion. 2.2xC, 2.2xCU)Product is distributed by Hamilton Medical, Inc., 4990 Energy Way, Reno, NV 89502
- Company
- Hamilton Medical Inc
- Recall Initiated
- May 24, 2006
- Posted
- July 22, 2006
- Terminated
- December 21, 2006
- Recall Number
- Z-1251-06
- 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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