Z-2139-2021Class II

CARESCAPE PDM-Masimo SpO2. Physiological data monitor

Name: Z-2139-2021 CARESCAPE PDM-Masimo SpO2. Physiological data monitor
Creator: GE Healthcare, LLC
Published: 2021-05-21
License: https://open.fda.gov/license/

GE Healthcare / initiated 2021-05-21 / Open, Classified / root cause: software

FDA source

GE Healthcare, LLC began a recall of CARESCAPE PDM-Masimo SpO2. Physiological data monitor on 2021-05-21. FDA classified it as Class II and gives the reason as "Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2139-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-21
Posted: 2021-07-23
Recalling firm: GE Healthcare
Product: CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2139-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2139-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-04	2021-07-23

Product code MHX

K071073Class IISolar 8000 and Transport Pro with Patient Data ModuleGe Medical Systems Information Technologies / cleared 2007-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)