Z-2046-2018 Class I Terminated
FDA device recall Z-2046-2018 was initiated by Draeger Medical Systems, Inc. on May 15, 2018 and is designated Class I. Reason for recall: Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement. The recall status is terminated (terminated February 8, 2023). Affected quantity: 10363.
Recall Details
- Product Type
- Devices
- Report Date
- June 13, 2018
- Initiation Date
- May 15, 2018
- Termination Date
- February 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10363
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, 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, TN, TX, UT, VA, VT, WA, WI, WV, WY; and countries of: Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Benin, Bolivia, Bosnia-Herz., Botswana, Brazil, British Virgin Islands, Brunei Darussalam, Bulgaria, Burkina-Faso, Cambodia, Canada, Chile, Columbia, Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Guiana, Macedonia, Georgia, Germany, Ghana, Greece, Greenland, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Kosovo, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nicaragua, Nigeria, Norway, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, St Vincent, St Pier Miquel, Sweden, Switzerland, Tadzhikistan, Tanzania, Thailand, Trinidad Tobago, Tunisia, Turkey, Turkmenistan, United Kingdom, Uruguay, UAE, Venezuela, Vietnam, and Zimbabwe.