| |
Class 2 Device Recall Philips |
 |
| Date Initiated by Firm |
August 11, 2021 |
| Create Date |
September 03, 2021 |
| Recall Status1 |
Completed |
| Recall Number |
Z-2419-2021 |
| Recall Event ID |
88491 |
| 510(K)Number |
K173451
|
| Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
| Product |
Ingenia Elition X-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: 781358
|
| Code Information |
Serial Number Unique Device Identifier (UDI#)
Model: 781358
45153 (01)00884838088115(21)45153
45062 (01)00884838088115(21)45062
45107 (01)00884838088115(21)45107
45144 (01)00884838088115(21)45144
45145 (01)00884838088115(21)45145
45142 (01)00884838088115(21)45142
45215 (01)00884838088115(21)45215
45216 (01)00884838088115(21)45216
45284 (01)00884838088115(21)45284
45079 (01)00884838088115(21)45079
45121 (01)00884838088115(21)45121
45007 (01)00884838088115(21)45007
45154 (01)00884838088115(21)45154
45127 (01)00884838088115(21)45127
45052 (01)00884838088115(21)45052
45193 (01)00884838088115(21)45193
45253 (01)00884838088115(21)45253
45042 (01)00884838088115(21)45042
45045 (01)00884838088115(21)45045
45136 (01)00884838088115(21)45136
45119 (01)00884838088115(21)45119
45197 (01)00884838088115(21)45197
45195 (01)00884838088115(21)45195
45097 (01)00884838088115(21)45097
45106 N/A
45131 N/A
45259 (01)00884838088115(21)45259
45300 (01)00884838088115(21)45300
45313 (01)00884838088115(21)45313
45298 (01)00884838088115(21)45298
45265 (01)00884838088115(21)45265
45000 (01)00884838088115
45039 (01)00884838088115(21)45039
45047 (01)00884838088115(21)45047
45080 (01)00884838088115(21)45080
45056 (01)00884838088115(21)45056
45137 (01)00884838088115(21)45137
45129 (01)00884838088115(21)45129
45109 (01)00884838088115(21)45109
45171 (01)00884838088115(21)45171
45205 (01)00884838088115(21)45205
45210 (01)00884838088115(21)45210
45188 (01)00884838088115(21)45188
45297 (01)00884838088115(21)45297
45071 (01)00884838088115(21)45071
45098 (01)00884838088115(21)45098
45140 (01)00884838088115(21)45140
45246 (01)00884838088115(21)45246
45159 (01)00884838088115(21)45159
45031 (01)00884838088115(21)45031
45044 (01)00884838088115(21)45044
45043 (01)00884838088115(21)45043
45040 (01)00884838088115(21)45040
45065 (01)00884838088115(21)45065
45070 (01)00884838088115(21)45070
45260 (01)00884838088115(21)45260
45088 (01)00884838088115(21)45088
45096 (01)00884838088115(21)45096
45128 (01)00884838088115(21)45128
45134 (01)00884838088115(21)45134
45111 (01)00884838088115(21)45111
45190 (01)00884838088115(21)45190
45218 (01)00884838088115(21)45218
45139 (01)00884838088115(21)45139
45241 (01)00884838088115(21)45241
45025 (01)00884838088115(21)45025
45114 (01)00884838088115(21)45114
45151 (01)00884838088115(21)45151
45148 (01)00884838088115(21)45148
45160 (01)00884838088115(21)45160
45176 (01)00884838088115(21)45176
45274 (01)00884838088115(21)45274
45276 (01)00884838088115(21)45276
45282 (01)00884838088115(21)45282
45248 (01)00884838088115(21)45248
45138 (01)00884838088115(21)45138
45295 (01)00884838088115(21)45295
45033 (01)00884838088115(21)45033
45048 (01)00884838088115(21)45048
45037 (01)00884838088115(21)45037
45050 (01)00884838088115(21)45050
45049 (01)00884838088115(21)45049
45046 (01)00884838088115(21)45046
45034 (01)00884838088115(21)45034
45066 (01)00884838088115(21)45066
45061 (01)00884838088115(21)45061
45076 (01)00884838088115(21)45076
45072 (01)00884838088115(21)45072
45077 (01)00884838088115(21)45077
45090 (01)00884838088115(21)45090
45041 (01)00884838088115(21)45041
45091 (01)00884838088115(21)45091
45093 (01)00884838088115(21)45093
45102 (01)00884838088115(21)45102
45105 (01)00884838088115(21)45105
45120 (01)00884838088115(21)45120
45064 (01)00884838088115(21)45064
45084 (01)00884838088115(21)45084
45170 (01)00884838088115(21)45170
45118 (01)00884838088115(21)45118
45163 (01)00884838088115(21)45163
45116 (01)00884838088115(21)45116
45149 (01)00884838088115(21)45149
45141 (01)00884838088115(21)45141
45162 (01)00884838088115(21)45162
45185 (01)00884838088115(21)45185
45115 (01)00884838088115(21)45115
45186 (01)00884838088115(21)45186
45189 (01)00884838088115(21)45189
45211 (01)00884838088115(21)45211
45250 (01)00884838088115(21)45250
45224 (01)00884838088115(21)45224
45272 (01)00884838088115(21)45272
45281 (01)00884838088115(21)45281
45212 (01)00884838088115(21)45212
45231 (01)00884838088115(21)45231
45290 (01)00884838088115(21)45290
45314 (01)00884838088115(21)45314
45323 (01)00884838088115(21)45323
45268 (01)00884838088115(21)45268
45123 (01)00884838088115(21)45123
45122 (01)00884838088115(21)45122
45169 N/A
45168 (01)00884838088115(21)45168
45191 (01)00884838088115(21)45191
45220 (01)00884838088115(21)45220
45204 (01)00884838088115(21)45204
45192 N/A
45229 (01)00884838088115(21)45229
45203 (01)00884838088115(21)45203
45222 (01)00884838088115(21)45222
45228 (01)00884838088115(21)45228
45207 (01)00884838088115(21)45207
45249 (01)00884838088115(21)45249
45279 (01)00884838088115(21)45279
45278 (01)00884838088115(21)45278
45320 (01)00884838088115(21)45320
45156 (01)00884838088115(21)45156
45157 (01)00884838088115(21)45157
45085 (01)00884838088115(21)45085
45303 (01)00884838088115(21)45303
45304 (01)00884838088115(21)45304
45307 (01)00884838088115(21)45307
45305 (01)00884838088115(21)45305
45306 (01)00884838088115(21)45306
45308 (01)00884838088115(21)45308
45309 (01)00884838088115(21)45309
45311 (01)00884838088115(21)45311
45310 (01)00884838088115(21)45310
45312 (01)00884838088115(21)45312
45267 (01)00884838088115(21)45267
45001 (01)00884838088115
45008 (01)00884838088115(21)45008
45009 N/A
45036 (01)00884838088115(21)45036
45181 (01)00884838088115(21)45181
45184 (01)00884838088115(21)45184
45227 (01)00884838088115(21)45227
45217 (01)00884838088115(21)45217
45187 N/A
45292 (01)00884838088115(21)45292
45219 (01)00884838088115(21)45219
45180 (01)00884838088115(21)45180
45067 (01)00884838088115(21)45067
45094 (01)00884838088115(21)45094
45183 (01)00884838088115(21)45183
45081 (01)00884838088115(21)45081
45095 (01)00884838088115(21)45095
45028 (01)00884838088115(21)45028
45029 N/A
45030 (01)00884838088115(21)45030
45165 (01)00884838088115(21)45165
45158 (01)00884838088115(21)45158
45177 (01)00884838088115(21)45177
45174 (01)00884838088115(21)45174
45002 (01)00884838088115
45010 (01)00884838088115(21)45010
45011 (01)00884838088115(21)45011
45026 (01)00884838088115(21)45026
45027 (01)00884838088115(21)45027
45024 (01)00884838088115(21)45024
45035 (01)00884838088115(21)45035
45032 (01)00884838088115(21)45032
45051 (01)00884838088115(21)45051
45054 (01)00884838088115(21)45054
45053 (01)00884838088115(21)45053
45078 (01)00884838088115(21)45078
45068 (01)00884838088115(21)45068
45089 (01)00884838088115(21)45089
45082 (01)00884838088115(21)45082
45055 (01)00884838088115(21)45055
45086 (01)00884838088115(21)45086
45060 (01)00884838088115(21)45060
45100 (01)00884838088115(21)45100
45112 (01)00884838088115(21)45112
45099 (01)00884838088115(21)45099
45075 (01)00884838088115(21)45075
45087 (01)00884838088115(21)45087
45108 (01)00884838088115(21)45108
45113 (01)00884838088115(21)45113
45146 (01)00884838088115(21)45146
45124 (01)00884838088115(21)45124
45147 (01)00884838088115(21)45147
45164 (01)00884838088115(21)45164
45150 (01)00884838088115(21)45150
45133 (01)00884838088115(21)45133
45152 (01)00884838088115(21)45152
45161 (01)00884838088115(21)45161
45178 (01)00884838088115(21)45178
45132 (01)00884838088115(21)45132
45179 (01)00884838088115(21)45179
45194 (01)00884838088115(21)45194
45237 (01)00884838088115(21)45237
45236 (01)00884838088115(21)45236
45238 (01)00884838088115(21)45238
45243 (01)00884838088115(21)45243
45252 (01)00884838088115(21)45252
45245 (01)00884838088115(21)45245
45263 (01)00884838088115(21)45263
45261 (01)00884838088115(21)45261
45269 (01)00884838088115(21)45269
45264 (01)00884838088115(21)45264
45247 (01)00884838088115(21)45247
45296 (01)00884838088115(21)45296
45321 (01)00884838088115(21)45321
45092 (01)00884838088115(21)45092
45155 (01)00884838088115(21)45155
45058 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 |
228 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.
|
|
|
|
