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Terminated

IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system. Model: M3001A

FDA Recall Z-1487-06 · Posted 2006-09-12

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeDQA
Date Initiated2006-07-24
Date Terminated2020-08-11
Product Quantity48,699 units

Reason for Recall

Patient monitor may display inaccurate reading when the Disposable Sp02 Sensor is not attached

Firm 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.

Root Cause

Other

Distribution Pattern

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, Yemen, UK, Zimbabwe, Zambia, India, Indonesia, Japan, Korea, Philipines, Malaysia, Singapore, Sri Lanka, Taiwan, Vietnam, Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033715PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVERPhilips Medical Systems, Inc. · 2004-02-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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