Hamilton brand RAPHAEL Color Ventilator (Software Vesion. 2.2xC, 2.2xCU)Product is distributed by Hamilton Medical, Inc.
FDA device recall Z-1251-06 · posted 2006-07-22 · Terminated
Recall details
- Recalling firm
- Hamilton Medical Inc
- Reason for recall
- ALARM FAILURE-Following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 2,385 for all models
- Distribution
- Worldwide
- Date initiated
- 2006-05-24
- Date posted
- 2006-07-22
- Date terminated
- 2006-12-21
- Location
- Reno, NV
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RAPHAEL COLOR (K052863) | Hamilton Medical AG | 2006-01-06 |
| RAPHAEL (K022679) | Hamilton Medical AG | 2003-10-22 |