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,
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-1249-06
- 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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