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U.S. Department of Health and Human Services

Class 2 Device Recall HA FlexTrak

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 Class 2 Device Recall HA FlexTraksee related information
Date Initiated by FirmMay 03, 2024
Date PostedJune 04, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1948-2024
Recall Event ID 94603
510(K)NumberK213583 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductHA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411
Code Information UDI: N/A Serial Numbers: 3 5 6 9 11 12 13 14 15 16 17 18 19 20 22 23 25 26 29 30 31 32 33 34 35 37 38 39 41 42 43 44 45 49 50 51 52 53 55 56 58 61 63 64 66 67 68 70 71 72 73 75 77 79 80 81 82 83 84 86 87 88 89 91 93 94 95 97 98 100 101 102 103 104 105 107 108 109 110 111 112 113 114 115 116 117 118 119 120 122 123 124 125 126 129 130 132 133 135 136 137 138 139 140 141 142 143 146 148 149 150 151 152 153 154 155 156 158 159 160 161 162 163 164 165 167 169 170 171 172 173 174 175 177 180 181 183 184 185 186 188 189 190 191 192 193 195 196 197 198 200 201 202 203 204 205 206 207 208 209 211 212 213 215 216 218 219 220 221 222 223 224 225 226 228 229 232 233 234 235 236 237 238 240 241 242 243 244 246 248 250 251 253 254 255 257 258 259 260 262 263 264 265 267 269 270 272 273 274 275 278 279 281 282 284 286 287 288 289 290 291 292 293 294 295 296 297 298 301 302 303 304 305 307 308 309 310 311 312 313 314 315 317 318 319 320 322 323 324 325 326 328 331 332 334 335 336 337 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101777 101778
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
For Additional Information ContactCustomer Care Solution Center
800-722-9377
Manufacturer Reason
for Recall		Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
FDA Determined
Cause 2		Under Investigation by firm
ActionPhilips NA issued URGENT Medical Device Correction letter to US consigneess dated May 3, 2024 via FedEx. Philips Markets Organizations are responsible for distributing the letters outside of the US. Letter states reason for recall, health risk and action to take: A. If you see hydraulic fluid (oil) leakage: " First remove fluid from the floor using a paper towel. Then remove any remaining oil film from the floor using a cleaning agent (e.g. soap and water) and paper towel. " Contact your local Philips service representative. B. You may continue to use your HA FlexTrak Trolley in accordance with the intended use. C. Circulate this notice to all users of this device so that they are aware of the issue and associated hazard/harm until this issue has been resolved. D. Please post this letter near the associated MR system(s) for ease of reference. E. Complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the URGENT Medical Device Correction, understanding of the issue, and required actions to be taken. A Philips representative will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site to inspect the HA FlexTrack Trolley and correct if required (reference FCO78100580). If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377, 8AM-8PM EST, Monday-Friday).
Quantity in Commerce1348 units
DistributionWorldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Fiji, Finland, France, French Guiana, Germany, Guadeloupe, Honduras, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Jordan, Lithuania, Martinique, Mexico, Morocco, Netherlands, Norway, Oman, Peru, Poland, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LNH
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