M3001A Philips Multi Measurement Server (MMS)
- Company
- Philips Medical Systems
- Recall Initiated
- September 21, 2006
- Posted
- November 16, 2006
- Terminated
- August 11, 2020
- Recall Number
- Z-0183-2007
- Quantity
- 69696 units
- Firm Location
- Andover, MA
Reason for Recall
Unexpected pulse oximetry (Sp02) readings (100%) over time when a sensor is not attached to the patient. In addition, with a sensor attached to a patient, an incorrect high Sp02 may be displayed when a pulse rate is in a range of 185BPM
Distribution
Worldwide, including USA, Canada, Australia, China, Hong Kong, India, Indonesia, Japan, Phillipines, Singapore, Taiwan, Thailand, Vietnam, Argentina, Brazil, Chile, Colombia, El Salvador, Jamaica, Mexico, Nicaragua. Panama, Paraguay, Peru, Venezuela, Austria, Belgium, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Germany, Israel, Italy, Jordan, Kenya, Kuwait, Lebanon, Lithuania, Luxembourg, Macedonia, Mauritania, Mauritius, Netherlands, Norway, Oman, Slovenia, South Africa, Spain, Switzerland, Turkey, UAE, UK, Yemen, Zambia, Zimbabwe
Lot / Code Info
HW Revision B: M3001 A #AO1 with S/N DE512xxxx M3001A #A02 with S/N DE512xxxx HW Revision C M3001A #A01 and #A02 with S/N DE610xxxx With Sp)2 Firmware (Fw) Rev.: Sp02 DSP FW-Rev: A.01.41 or A.01.42
Root Cause
Other
Action Taken
Philips issued a Customer Letter and Urgent Device Correction letter to consignees on 09/21/06. Users were notified of the problem and provided with Instructions to Mitigate Risk. A software upgrade to: version D.00.61 and Sp02 FW A.01.46 is mandatory.