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Terminated

The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.

FDA Recall Z-2760-2016 · Posted None

Recalling FirmInvivo Corporation
Recall StatusTerminated
Product CodeMWI
Date Initiated2015-10-19
Date Terminated2019-10-04
Product Quantity2,929

Reason for Recall

Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze

Firm Action

Phillips Medical Systems sent out a letter to their customers, dated October 19, 2015. The letter notified customers and distributors of the voluntary recall of the Xper Flex Cardio Patient Monitoring System, and identified the product issue as "Display o fSpO2 and NIBP measurements may freeze". Phillips assured customers that the recalled device can be used if each monitored patient is closely observed and not left unattended. These directions are directed within the instructions of the manual for regular use. Continued use is advised until Phillips contacts the individual customer to correct the issue with a software update. Some hardware is more dated, so software updates will require special handling. If customers have any additional questions, they are encouraged to contact their local Phillips representative. For further questions, please call (877) 468- 4861 option 1 then option 2.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Nationwide Distribution to the states of :AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TX, TN, UT, VA, WA, WI, WV, Alaska, Hawaii, & Washington, DC. Worldwide Distribution to the countries of : Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Canada, Cayman Islands, Chile, Columbia, Croatia, Democratic Republic of Congo, Denmark, Ecuador, Egypt, Estonia, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jordan, Kazakhstan, Republic of Korea, Lebanon, Libya, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, State of Palestine, Panama, Papua New Guinea, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Taiwan Province, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, United Republic of Tanzania, Uzbekistan, & Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101571XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMSWitt Biomedical Corp · 2010-10-26

Official Source

View FDA Recall →

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

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