Hamilton brand RAPHAEL Color Ventilator (Software Vesion. 2.2xC, 2.2xCU)Product is distributed by Hamilton Medical, Inc., 4990 Energy Way, Reno, NV 89502
This recall has been terminated (originally issued July 22, 2006).
- 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
- Official Source
- View on FDA website ↗
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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