Recall Z-1249-06 ยท CBK Ventilator, Continuous, Facility Use
Hamilton Medical Inc
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,
| Date | Jul 22, 2006 (initiated May 24, 2006) |
| Status | Terminated |
| Reason | ALARM FAILURE-Following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system. |
| Root cause | Other |
| 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. |
| Quantity | 2,385 for all models |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |