Reason: This product is not cleared for marketing in the US.
Distributed: Nationwide Distribution.Reason: This product is not cleared for marketing in the US.
Distributed: Nationwide Distribution.Reason: The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents the customers from doing the Daily Image Quality Checks as defined in the current Instructions for Use (IfU).
Distributed: Worldwide Distribution - USA ( nationwide) including the states of AK, AL, AR, AZ, CA, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, VA, WA, WV and WY, and the countries of Albania, Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, China, Colombia, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Ghana, Gibraltar, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Venezuela, Viet Nam & Yemen.Reason: GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
Distributed: Nationwide Distribution including NM, WY, FL, MO, MA, and MI.Reason: When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposure techniques than selected, and may not display AEC setting. The exposure can still be made as commanded, however it may not be properly indicated.
Distributed: Nationwide DistributionReason: When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposure techniques than selected, and may not display AEC setting. The exposure can still be made as commanded, however it may not be properly indicated.
Distributed: Nationwide DistributionReason: Liko/Hill-Rom to date has received two reports from facilities alleging that the overhead rail system has failed to the extent that the overhead rails have fallen down while in use in high humidity (swimming pool) areas. Analysis of the incidents suggest that the components (hardware) used to secure the rail to the ceiling had corroded and may be unsuitable for environments with an atmosphere con
Distributed: Worldwide Distribution: USA (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, WA, WI, WV, and WY; and CANADA LOCATIONS: AB, BC, MB, NB, NS, ON, and SK.Reason: Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use
Distributed: Worldwide Distribution - USA (nationwide) and Internationally to ALGERIA, ANGOLA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BULGARIA, COLOMBIA, CROATIA (LOCAL NAME HYVATSKA), CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, ESTONIA, FINLAND, FRANCE, GABON, GERMANY, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN (ISLAMIC REPUBLIC OF), IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MALAYSIA, MALTA, MAURITIUS, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PALESTINE, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA (SLOVAK REPUBLIC), SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, AND VIET NAM.Reason: The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory.
Distributed: Worldwide Distribution including USA nationwide.Reason: Integra determined there is a possibility that the Base Units may break during use.
Distributed: Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA & WI. Internationally to Belgium.