FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1249-06
- Recalling firm
- Hamilton Medical Inc
- 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,
- Status
- Terminated
- Initiated
- 2006-05-24
- Posted
- 2006-07-22
- Terminated
- 2006-12-21
- 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
- Lot, serial or model codes
- Serial Numbers 2975 to 5360
- 510(k) numbers
- ["K022679","K052863"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 2937708
- Firm city
- Reno
- Firm state
- NV
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28