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GE Healthcare, LLC Recall 88106

Description: CARESCAPE PDM-Masimo SpO2. Physiological data monitor.

GE Healthcare, LLC Recall 88106 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2139-2021
Event ID88106
Event DescriptionCARESCAPE PDM-Masimo SpO2. Physiological data monitor.
Product TypeDevices
Distributionworldwide 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.
Quantity94,462 units
Recall ReasonMasimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
Device Classification20210804
Device Code InfoCARESCAPE PDM: product codes SA3, SPX; model numbers 2042084-001, 2094504-001 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
Center Classification Date20210723
Recall Initiation Date20210521
Recalling FirmGE Healthcare, LLC
Initial Notification Letter
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