RecallDepth

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

Company
Philips Medical Systems
Recall Initiated
July 24, 2006
Posted
September 12, 2006
Terminated
August 11, 2020
Recall Number
Z-1487-06
Quantity
48,699 units
Firm Location
Andover, MA

Reason for Recall

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

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

Lot / Code Info

M3001A options A01, A01C06, A01C12, and A01C18 with serial number prefix DE512 and MMS software revision C.0 or B.1 M3001A options A02, A02C06, and A02C18 with serial number prefix DE441 and DE512 and MMS software revision C.0 or B.1

Root Cause

Other

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.

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