IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system. Model: M3001A
FDA device recall Z-1487-06 · posted 2006-09-12 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Patient monitor may display inaccurate reading when the Disposable Sp02 Sensor is not attached
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 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,
- Date initiated
- 2006-07-24
- Date posted
- 2006-09-12
- Date terminated
- 2020-08-11
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER (K033715) | Philips Medical Systems, Inc. | 2004-02-13 |