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Open, Classified

CARESCAPE PDM-Masimo SpO2. Physiological data monitor.

FDA Recall Z-2139-2021 · Posted 2021-07-23

Recalling FirmGE Healthcare, LLC
Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2021-05-21
Product Quantity111,728 units

Reason for Recall

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

Firm 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

Root Cause

Software Manufacturing/Software Deployment

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071073SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULEGe Medical Systems Information Technologies · 2007-05-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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