Recalls / —

—#187878

Product

CARESCAPE PDM-Masimo SpO2. Physiological data monitor.

FDA product code

MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K071073

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Software Manufacturing/Software Deployment

Action the firm took

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

Recalling firm

Firm

GE Healthcare, LLC

Address

3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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.

Timeline

Recall initiated

2021-05-21

Posted by FDA

2021-07-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #187878. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.