Reason: Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Distributed: Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.Reason: Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Distributed: Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.Reason: Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Distributed: Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.Reason: Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Distributed: Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.Reason: Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Distributed: Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.Reason: It was discovered that the silicone potting failed to properly cure after undergoing the prescribed curing possess. The potting material is used to insulate, stabilize and provide a moisture barrier to the TPS MicroDriver main Printed Circuit Board Assembly (PCBA). Inadequate cure of the silicone potting could potentially allow it to leak to the outside of the handpiece or cause an electrical ma
Distributed: Worldwide distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Italy, Japan, Spain, Switzerland, and United Kingdom.Reason: Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip.
Distributed: Worldwide distribution: US (nationwide) and country of: Canada.Reason: During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact. This issue was discovered in manufacturing. It occurs when the DRX product console software is updated to v5.6b software and the detector is not calibrated before use.
Distributed: Worldwide Distribution - US (nationwide) including the states of New York, Massachusetts, Pennsylvania, Illinois, Texas, California and Louisiana., and the countries of Australia, Canada, Finland, Italy, Switzerland and United Kingdom.Reason: Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position.
Distributed: Worldwide Distribution - USA including AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, KY, MA, MD, MN, MO, MS, MT, NC, NJ, ND, NE, NV, NY, OH, OK, OR, PA, SD, TX, VT, WA, and WI. Internationally to Canada, Algeria, Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, Denmark, Finland, France, Gabon, Germany, India, Indonesia, Ireland, Italy, Japan, Korea Republic, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.Reason: Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.
Distributed: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, Chile, China, Denmark, Egypt, Finland, France, Greece, Germany, India, Indonesia, Israel, Ireland, Italy, Kuwait, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.