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Recall Observatory FDA recall evidence

Device product

CARESCAPE PDM-Masimo SpO2. Physiological data monitor.

Z-2139-2021

May 21, 2021

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 88106
Status
Ongoing
Classification
Class II
Quantity
111,728 units
Official record key
device-enforcement:Z-2139-2021

Official wording

Reason: Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.

Code information: CARESCAPE PDM: product codes SA3, SPX; model numbers 2042084-001, 2094504-001, 2016793-002, 2016793-003; Software kits, field replaceable units, and upgrade kits: part numbers 2034826-001, 2034826-002, 2034826-003, 2034826-004, 2034826-005, 2034826-006, 2034826-007, 2034826-008, 2034826-009, 2034826-010, 2034826-011, 2034826-012, 2034826-013, 2031069-010, 2045825-001, 2045825-002, 2045825-004, 2045825-005

Distribution pattern: worldwide distribution US nationwide, Albania, Algeria, Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Fiji, Finland, France, Germany, Ghana, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Iran, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Libya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, State of Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.