CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
Reported: August 4, 2021 Initiated: May 21, 2021 #Z-2139-2021
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.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 111,728 units
- 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.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.. Recalled by GE Healthcare, LLC. Units affected: 111,728 units.
Why was this product recalled? ▼
Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 4, 2021. Severity: Moderate. Recall number: Z-2139-2021.
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