Radical Handheld Pulse Oximeter
FDA device recall Z-0933-05 · posted 2005-06-25 · Terminated
Recall details
- Recalling firm
- Masimo Corporation
- Reason for recall
- Speaker component failure resulting in ceasation of an audible alarm even though the condition continues that caused the alarm.
- Action taken
- Recall was by letter to all customers who received units made before 12/11/01. They are to return for repair or have them fixed by an Authorized Masimo Service Representative.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 8,110
- Distribution
- Nationwide and Korea, Hong Kong, Canada, New Zealand, Thailand, Argentina, Portugal, Malaysia, Ireland, Australia, japan, France, El Salvador, South Africa, UAE-Saudi Arabia, Germany, Mexico, Unitied
- Date initiated
- 2005-06-10
- Date posted
- 2005-06-25
- Date terminated
- 2008-06-17
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PE (K992340) | Masimo Corp. | 1999-10-08 |