Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1487-06

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

Philips North America LLC / initiated 2006-07-24 / Terminated

Philips Medical Systems began a recall of IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system. Model: M3001A on . The reason FDA records is "Patient monitor may display inaccurate reading when the Disposable Sp02 Sensor is not attached". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1487-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
Product
IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system. Model: M3001A
Product code
DQA Oximeter
Reason for recall
Patient monitor may display inaccurate reading when the Disposable Sp02 Sensor is not attached
FDA 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 in commerce
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, Yemen, UK, Zimbabwe, Zambia, India, Indonesia, Japan, Korea, Philipines, Malaysia, Singapore, Sri Lanka, Taiwan, Vietnam, Venezuela.
Product codes and lots
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