Home / Recalls / GE Healthcare, LLC / Z-2139-2021

Z-2139-2021 Class II Ongoing

Recalled by GE Healthcare, LLC — Waukesha, WI

Recall Details

Product Type
Devices
Report Date
August 4, 2021
Initiation Date
May 21, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
111,728 units

Product Description

CARESCAPE PDM-Masimo SpO2. Physiological data monitor.

Reason for Recall

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

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.

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

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  • Z-0318-2025 Class II — GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2 (October 3, 2024)
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