Class 2 Device Recall MDEleva, UDEleva

• Date Initiated by Firm: March 26, 2018
• Date Posted: May 03, 2018
• Recall Status: Terminated on June 12, 2020
• Recall Number: Z-1606-2018
• Recall Event ID: 79783
• 510(K)Number: K050151
• Product Classification: System, x-ray, stationary - Product Code KPR
• Product: Mutlidiagnost-Eleva with Flat Detector 708034; ; As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
• Code Information: System Serial # 201 137 223 228 219 60 272 35 111 85 121 38 120 185 168 32 30 100 235 34 148 149 67 269 191 118 170 241 210 255 8 273 33 240 131 99 193 36 138 96 222 278 257 246 23 147 162 220 47 179 221 126 195 46 144 254 189 75 56 217 83 5 167 6 154 155 156 177 183 157 245 116 62 207 81 113 134 103 115 55 200 180 175 78 93 24 106 110 123 266 3 URF.173 14 202 208 247 225 28 216 262 9 176 261 259 174 114 68 63 122 135 205 224 39 98 80 22 251 142 253 84 181 264 163 73 94 95 160 199 206 159 112 196 151 25 238 150 4 117 50 58 51 79 249 119 204 133 18 13 15 16 17 129 244 227 234 130 31 12 27 11 128 171 237 76 1 143 248 109 42 43 44 172 213 212 2 48 127 19 82 69 70 65 242 54 194 136 190 152 105 233 71 97 132 197 53 211 72 187 209 41 146 125 268 26 77 40
• Recalling Firm/ Manufacturer: Philips Medical Systems Nederlands; Veenpluis 4-6; Best Netherlands
• Manufacturer Reason for Recall: The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm, BU IGT Systems, sent an "URGENT- Field Safety Notice" letter dated 3/23/2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to stop using the system and call your Philips representative if the following situations occurs: -the table height or tilt movement is not working. - you notice a cracking or snapping sound during system operation. - you experience a blockade in the table height or tilt movement during system movements. -the system is having an unexpected collision or the system had an unexpected collision in the past 2 months. - you have used a CPR stand that obstructed the system, or - you notice any (other) unusual system behavior beyond the normal use of the system. The customers should also avoid collisions with the table and base stand of the system by ensuring that no obstacles are placed around the system. In addition, ensure that all staff with access to the affected systems are informed of the content of this Field Safety Notice. The firm stated: -All possibly affected products in the field will be corrected by means of a field change order free of charge. -A firm representative will replace affected material on the upper and lower tilt actuator in the affected systems. -You will be contacted by our local Philips representative to schedule this corrective action. -This action will start effective April 2018. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722- 9377, 8am to 8pm (EST) Monday thru Friday.
• Quantity in Commerce: 206
• Distribution: Worldwide Distribution: US (Nationwide) and countries of: Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Farce Islands, Finland, France, Germany, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Korea, Republic of, Latvia, Lebanon, Luxembourg, Malaysia, Martinique Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.