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Rainbow Reusable Sensors (2016-04-22)
- Starting date:
- April 22, 2016
- Posting date:
- May 16, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-58426
Affected Products
Rainbow Reusable Sensors
Reason
Masimo has identified specific lots of sensors that were manufactured with incompatible configurations. This could result in sensors that will either not provide readings for the SpCO and SpMet parameters or inaccurate readings. The specific behavior will depend on the firmware version of the technology board in the device. SpCO measurements, when displayed, could be incorrectly elevated throughout the measurement range. SpMet measurements above 6% could be affected by a negative bias of 1.5%, on average.
Affected products
Rainbow Reusable Sensors
Lot or serial number
- BOX LOT # 15JA8
- BOX LOT 15HA6
- Sensor Ref#-LOT# 24087-A15G760
- Sensor Ref#-LOT# 24087-A15H754
- Sensor Ref#-LOT# 24087-A15J726
- Sensor Ref#-LOT# 24087-A15J824
- Sensor Ref#/LOT# 24087-A15H754
Model or catalog number
- 2696
Companies
- Manufacturer
-
Masimo Corporation
40 Parker
Irvine
California
UNITED STATES