| |
Class 2 Device Recall Philips |
 |
| Date Initiated by Firm |
August 11, 2021 |
| Create Date |
September 03, 2021 |
| Recall Status1 |
Completed |
| Recall Number |
Z-2420-2021 |
| Recall Event ID |
88491 |
| 510(K)Number |
K162931
|
| Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
| Product |
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities
Models: 781271 |
| Code Information |
Serial Number Unique Device Identifier (UDI#)
Model: 781271
78121 (01)00884838068452(21)78121
78150 (01)00884838068452(21)78150
78157 (01)00884838068452(21)78157
78096 N/A
78208 (01)00884838068452(21)78208
78094 N/A
78012 N/A
78074 N/A
78154 (01)00884838068452(21)78154
78161 N/A
78172 (01)00884838068452(21)78172
78170 (01)00884838068452(21)78170
78182 (01)00884838068452(21)78182
78183 (01)00884838068452(21)78183
78205 (01)00884838068452(21)78205
78196 (01)00884838068452(21)78196
78171 (01)00884838068452(21)78171
78213 (01)00884838068452(21)78213
78221 (01)00884838068452(21)78221
78210 (01)00884838068452(21)78210
78212 (01)00884838068452(21)78212
78233 (01)00884838068452(21)78233
78190 (01)00884838068452(21)78190
78198 (01)00884838068452(21)78198
78216 (01)00884838068452(21)78216
78225 (01)00884838068452(21)78225
78238 N/A
78242 (01)00884838068452(21)78242
78173 (01)00884838068452(21)78173
78251 (01)00884838068452(21)78251
78250 (01)00884838068452(21)78250
78241 (01)00884838068452(21)78241
78235 (01)00884838068452(21)78235
78262 (01)00884838068452(21)78262
78253 (01)00884838068452(21)78253
78244 (01)00884838068452(21)78244
78252 (01)00884838068452(21)78252
78256 (01)00884838068452(21)78256
78263 (01)00884838068452(21)78263
78257 N/A
78266 (01)00884838068452(21)78266
78267 (01)00884838068452(21)78267
78269 (01)00884838068452(21)78269
78265 (01)00884838068452(21)78265
78270 (01)00884838068452(21)78270
78284 (01)00884838068452(21)78284
78281 (01)00884838068452(21)78281
78289 (01)00884838068452(21)78289
78293 (01)00884838068452(21)78293
78271 (01)00884838068452(21)78271
78218 (01)00884838068452(21)78218
78291 (01)00884838068452(21)78291
78283 (01)00884838068452(21)78283
78273 (01)00884838068452(21)78273
78305 (01)00884838068452(21)78305
78268 (01)00884838068452(21)78268
78282 (01)00884838068452(21)78282
78279 (01)00884838068452(21)78279
78292 (01)00884838068452(21)78292
78309 (01)00884838068452(21)78309
78288 (01)00884838068452(21)78288
78314 (01)00884838068452(21)78314
78306 (01)00884838068452(21)78306
78319 (01)00884838068452(21)78319
78320 (01)00884838068452(21)78320
78307 (01)00884838068452(21)78307
78296 (01)00884838068452(21)78296
78280 (01)00884838068452(21)78280
78313 (01)00884838068452(21)78313
78317 (01)00884838068452(21)78317
78321 (01)00884838068452(21)78321
78322 (01)00884838068452(21)78322
78316 (01)00884838068452(21)78316
78310 (01)00884838068452(21)78310
78308 (01)00884838068452(21)78308
78312 (01)00884838068452(21)78312
78240 (01)00884838068452(21)78240
78329 (01)00884838068452(21)78329
78272 (01)00884838068452(21)78272
78189 (01)00884838068452(21)78189
78330 (01)00884838068452(21)78330
78332 (01)00884838068452(21)78332
78334 (01)00884838068452(21)78334
78340 (01)00884838068452(21)78340
78243 (01)00884838068452(21)78243
78294 (01)00884838068452(21)78294
78335 (01)00884838068452(21)78335
78345 (01)00884838068452(21)78345
78295 (01)00884838068452(21)78295
78333 (01)00884838068452(21)78333
78342 (01)00884838068452(21)78342
78341 (01)00884838068452(21)78341
78327 (01)00884838068452(21)78327
78347 (01)00884838068452(21)78347
78224 (01)00884838068452(21)78224
78030 N/A
78036 N/A
78059 N/A
78156 (01)00884838068452(21)78156
78249 (01)00884838068452(21)78249
78080 (01)00884838068452(21)78080
78078 (01)00884838068452(21)78078
78098 (01)00884838068452(21)78098
78003 N/A
78017 N/A
78065 N/A
78070 N/A
78081 N/A
78076 N/A
78087 N/A
78101 (01)00884838068452(21)78101
78097 (01)00884838068452(21)78097
78104 (01)00884838068452(21)78104
78099 (01)00884838068452(21)78099
78107 (01)00884838068452(21)78107
78126 (01)00884838068452(21)78126
78149 (01)00884838068452(21)78149
78151 (01)00884838068452(21)78151
78181 N/A
78219 (01)00884838068452(21)78219
78206 (01)00884838068452(21)78206
78264 (01)00884838068452(21)78264
78063 N/A
78064 N/A
78106 (01)00884838068452(21)78106
78187 (01)00884838068452(21)78187
78000 N/A
78005 N/A
78007 N/A
78009 N/A
78016 N/A
78015 N/A
78018 N/A
78023 N/A
78019 N/A
78021 N/A
78027 N/A
78010 N/A
78029 N/A
78031 N/A
78025 N/A
78033 N/A
78032 N/A
78038 N/A
78035 N/A
78039 N/A
78040 N/A
78045 N/A
78043 N/A
78042 N/A
78049 N/A
78048 N/A
78050 N/A
78051 N/A
78062 N/A
78068 (01)00884838068452(21)78068
78067 N/A
78072 (01)00884838068452(21)78072
78084 N/A
78089 (01)00884838068452(21)78089
78082 N/A
78083 (01)00884838068452(21)78083
78091 (01)00884838068452(21)78091
78095 (01)00884838068452(21)78095
78088 (01)00884838068452(21)78088
78100 (01)00884838068452(21)78100
78111 N/A
78115 (01)00884838068452(21)78115
78117 (01)00884838068452(21)78117
78113 (01)00884838068452(21)78113
78114 (01)00884838068452(21)78114
78109 (01)00884838068452(21)78109
78132 (01)00884838068452(21)78132
78127 (01)00884838068452(21)78127
78133 (01)00884838068452(21)78133
78139 (01)00884838068452(21)78139
78140 (01)00884838068452(21)78140
78129 (01)00884838068452(21)78129
78147 (01)00884838068452(21)78147
78148 (01)00884838068452(21)78148
78145 (01)00884838068452(21)78145
78155 (01)00884838068452(21)78155
78203 (01)00884838068452(21)78203
78199 (01)00884838068452(21)78199
78207 (01)00884838068452(21)78207
78222 (01)00884838068452(21)78222
78223 (01)00884838068452(21)78223
78214 (01)00884838068452(21)78214
78011 N/A
78014 N/A
78013 N/A
78028 N/A
78034 N/A
78044 N/A
78047 N/A
78046 N/A
78073 N/A
78058 N/A
78071 (01)00884838068452(21)78071
78086 N/A
78075 N/A
78066 N/A
78060 (01)00884838068452(21)78060
78092 (01)00884838068452(21)78092
78102 (01)00884838068452(21)78102
78077 (01)00884838068452(21)78077
78110 (01)00884838068452(21)78110
78112 (01)00884838068452(21)78112
78103 (01)00884838068452(21)78103
78120 (01)00884838068452(21)78120
78122 (01)00884838068452(21)78122
78123 (01)00884838068452(21)78123
78128 (01)00884838068452(21)78128
78118 (01)00884838068452(21)78118
78135 (01)00884838068452(21)78135
78142 (01)00884838068452(21)78142
78141 (01)00884838068452(21)78141
78158 (01)00884838068452(21)78158
78162 (01)00884838068452(21)78162
78165 (01)00884838068452(21)78165
78167 (01)00884838068452(21)78167
78138 (01)00884838068452(21)78138
78164 (01)00884838068452(21)78164
78166 (01)00884838068452(21)78166
78175 (01)00884838068452(21)78175
78180 (01)00884838068452(21)78180
78186 (01)00884838068452(21)78186
78188 (01)00884838068452(21)78188
78137 (01)00884838068452(21)78137
78195 (01)00884838068452(21)78195
78197 (01)00884838068452(21)78197
78209 (01)00884838068452(21)78209
78193 (01)00884838068452(21)78193
78201 (01)00884838068452(21)78201
78215 (01)00884838068452(21)78215
78217 (01)00884838068452(21)78217
78202 (01)00884838068452(21)78202
78232 (01)00884838068452(21)78232
78194 (01)00884838068452(21)78194
78227 (01)00884838068452(21)78227
78234 (01)00884838068452(21)78234
78255 (01)00884838068452(21)78255
78254 (01)00884838068452(21)78254
78247 (01)00884838068452(21)78247
78259 (01)00884838068452(21)78259
78239 (01)00884838068452(21)78239
78260 (01)00884838068452(21)78260
78261 (01)00884838068452(21)78261
78287 (01)00884838068452(21)78287
78286 (01)00884838068452(21)78286
78299 (01)00884838068452(21)78299
78290 (01)00884838068452(21)78290
78298 (01)00884838068452(21)78298
78297 (01)00884838068452(21)78297
78229 (01)00884838068452(21)78229
78277 (01)00884838068452(21)78277
78326 (01)00884838068452(21)78326
78337 (01)00884838068452(21)78337
78324 (01)00884838068452(21)78324
78336 (01)00884838068452(21)78336
78004 N/A
78008 N/A
78053 N/A
78026 N/A
78022 N/A
|
Recalling Firm/
Manufacturer |
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
|
Manufacturer Reason
for Recall |
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
|
FDA Determined
Cause 2 |
Device Design |
| Action |
Philips notified U.S. customers an Urgent Medical Device Correction letter on 8/11/21. Letter states reason for recall, health risk and action to take:
Philips advises that customers continue to utilize the primary motorized function for the MR system since the identified issue with the HDU does not occur in the motorized mode. If you utilize the manual function and it is not functioning properly, then you must perform table movement using the motorized function.
A Philips Field Service Engineer (FSE) will perform a HDU during the next scheduled preventive maintenance visit. If the issue is detected in the HDU, the Philips FSE will replace the necessary mechanical component(s) to resolve the issue.
If you need additional information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377) and reference FCO78100527. |
| Quantity in Commerce |
266 units |
| Distribution |
Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium
Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador,
Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy,
Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan,
Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg,
Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova,
Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan
Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico,
Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia,
Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic,
Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.
|
| 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.
|
| 510(K) Database |
510(K)s with Product Code = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
|
|
|
