—#48751

Product

M1020B PulseOximetry Module Philips FAST Sp02 and Pulse Oximetry Nellcor OxiMax Compatible used with the IntelliVue or M3/M4 patient monitor M1002

FDA product code: DQA — Oximeter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K033715
Affected lot / code info: M1020B #AO01 AND #A02 with S/N DE524xxxxx M102B #A01 and #A02 with S/N DE612xxxxx With Sp02 Firmware (Fw) Rev: Sp02 DSP Fw-Rev. A.01.42

Why it was recalled

Unexpected pulse oximetry (Sp02) readings (100%) over time when sensor is not attached to 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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2006-09-21
Posted by FDA: 2006-11-16
Terminated: 2020-08-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48751. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.