Company: Philips Medical Systems
Date of Enforcement Report:9/20/2006
Class:ll
PRODUCT
IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system. Model: M3001A, Recall # Z-1487-06
REASON
Patient monitor may display inaccurate reading when the Disposable Sp02 Sensor is not attached .
CODE
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
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, AndoverMA, by letter dated July 21, 2006.
Manufacturer: Philips Medizin Systeme Boblingen Gmbh, Boblingen, Federal Republic of Germany. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
55,901 units
DISTRIBUTION
Nationwide and Internationally