FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
- Recall number
- Z-2139-2021
- Recalling firm
- GE Healthcare, LLC
- Product
- CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
- Status
- Open, Classified
- Initiated
- 2021-05-21
- Posted
- 2021-07-23
- Terminated
- not on file
- Reason
- Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- On May 21st the firm sent a letter to its customers with the following instructions: You can continue to use the CARESCAPE PDM with Masimo SET technology by completing the power down instructions below annually. 1. If the PDM is on a patient, provide alternate monitoring if needed, during the power down process. 2. Disconnect the PDM from the display device by removing the PDM from the mounting dock or by disconnecting the communication cable from the back of the PDM. 3. Open the battery door compartment and remove the battery (if present), for approximately 10 seconds. 4. Reinsert the battery and reconnect the PDM to the display device
- Quantity
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K071073"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28