GE Healthcare, LLC Recall 88106
Description: CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
GE Healthcare, LLC Recall 88106 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2139-2021 |
| Event ID | 88106 |
| Event Description | CARESCAPE PDM-Masimo SpO2. Physiological data monitor. |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 94,462 units |
| Recall Reason | Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down. |
| Device Classification | 20210804 |
| Device Code Info | CARESCAPE 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 Date | 20210723 |
| Recall Initiation Date | 20210521 |
| Recalling Firm | GE Healthcare, LLC |
| Initial Notification | Letter |
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