Recall Z-1487-06 ยท DQA Oximeter
Philips Medical Systems
IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system. Model: M3001A
| Date | Sep 12, 2006 (initiated Jul 24, 2006) |
| Status | Terminated |
| Reason | Patient monitor may display inaccurate reading when the Disposable Sp02 Sensor is not attached |
| Root cause | Other |
| Action | Philips is using the contract services of Sterling, Indianapolis, IN to contact all consignees regarding the correction/upgrade to the device. The letter notification dated 7/21/06 was mailed UPS Delivery Tracking the week of 07/24/06. Additionally, Philips included with the Urgent Device Correction Notice a procedure to mitigate risk until the upgrade is installed. |
| Quantity | 48,699 units |
| Distribution | Worldwide, including USA, Canada, Argentina, Australia, Austria, Belgium, Brazil, Czech, Croatia, China, Denmark, Finland, France, Germany, Israel, Italy, Jordan, Kuwait, Luxemburg, Netherlands, Oman, Norway, Poland, Portugual, Poland, Russia, South Africa, Spain, Sweden, Swizerland, Turkey, UAE, Y |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033715 | PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER Philips Medical Systems, Inc., Feb 13, 2004 |