Philips Medical Systems M1020B PulseOximetry Module Philips FAST Sp02 and Pulse Oximetry Nellcor OxiMax Compatible used with the IntelliVue or M3/M4 patient monitor M1002 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
M1020B PulseOximetry Module Philips FAST Sp02 and Pulse Oximetry Nellcor OxiMax Compatible used with the IntelliVue or M3/M4 patient monitor M1002
Brand
Philips Medical Systems
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Philips Medical Systems is recalling M1020B PulseOximetry Module Philips FAST Sp02 and Pulse Oximetry Nellcor OxiMax Compatible used with due to Unexpected pulse oximetry (Sp02) readings (100%) over time when sensor is not attached to patient. In addition, with a sensor attached to a patient, a. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026