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U.S. Department of Health and Human Services

Class 2 Device Recall MDEleva, UDEleva

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 Class 2 Device Recall MDEleva, UDElevasee related information
Date Initiated by FirmMarch 26, 2018
Date PostedMay 03, 2018
Recall Status1 Terminated 3 on June 12, 2020
Recall NumberZ-1603-2018
Recall Event ID 79783
510(K)NumberK050151 
Product Classification System, x-ray, stationary - Product Code KPR
ProductMultiDim Eleva 708032 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 #  32 177 259 239 264 258 52 67 111 257 94 142 121 191 143 260 265 74 207 101 182 174 124 263 4 172 254 151 246 64 183 76 152 188 261 242 102 34 147 241 134 178 245 176 175 38 162 107 220 65 194 69 247 13 215 78 112 29 139 98 79 158 61 33 106 35 50 16 80 205 161 11 204 37 12 189 9 232 15 228 155 47 171 213 209 218 96 90 212 217 181 163 140 114 115 108 71 141 14 36 48 224 25 105 57 216 138 24 28 211 160 192 43 44 157 154 41 219 8 68 129 75 221 7 10 63 146 45 26 125 193 210 1 60 3 132 81 22 23 208 5 131 135 88 226 6 156 49 91 92 93 201 250 251 72 95 148 39 31 2 30 51 100 255 252 256 109 196 164 170 227 173 83 159 53 137 54 116 118 119 167 168 169 97 
FEI Number 3002807880
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 2		Nonconforming Material/Component
ActionThe 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 Commerce184
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = KPR
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