—#46876

Product

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

FDA product code: DQA — Oximeter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K033715
Affected 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

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems
Address: 3000 Minuteman Road, Andover, Massachusetts 01810-1032

Distribution

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.

Timeline

Recall initiated: 2006-07-24
Posted by FDA: 2006-09-12
Terminated: 2020-08-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #46876. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.