Z-1249-06

Hamilton brand RAPHAEL Ventilator (Software Versio 2.2x), Product is distributed by Hamilton Medical, Inc...

Name: Z-1249-06 Hamilton brand RAPHAEL Ventilator (Software Versio 2.2x), Product is distributed by Hamilton Medical, Inc...
Creator: Hamilton Medical Inc
Published: 2006-05-24
License: https://open.fda.gov/license/

Hamilton Medical AG / initiated 2006-05-24 / Terminated / root cause: manufacturing process

FDA source

Hamilton Medical Inc began a recall of Hamilton brand RAPHAEL Ventilator (Software Versio 2.2x), Product is distributed by Hamilton Medical, Inc., 4990 Energy Way,Reno, NV 89502-Serial Numbers 2975... on 2006-05-24. The reason FDA records is "ALARM FAILURE-Following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1249-06
Status: Terminated
Initiated: 2006-05-24
Posted: 2006-07-22
Terminated: 2006-12-21
Recalling firm: Hamilton Medical AG
Product: 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,
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: ALARM FAILURE-Following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system.
Root cause tag: manufacturing process
FDA 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 in commerce: 2,385 for all models
Distribution: Worldwide
Product codes and lots: Serial Numbers 2975 to 5360

Product code CBK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)