Recall Z-0933-05 ยท DQA Oximeter
Masimo Corporation
Radical Handheld Pulse Oximeter
| Date | Jun 25, 2005 (initiated Jun 10, 2005) |
| Status | Terminated |
| Reason | Speaker component failure resulting in ceasation of an audible alarm even though the condition continues that caused the alarm. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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 Kingdom, Singapore, Germany, Kuwait, Chile, Spain, Iceland, Italy, Poland, Sweden, Norway, Venezuela |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992340 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PE Masimo Corp., Oct 8, 1999 |