| | Class 2 Device Recall Philips |  |
| Date Initiated by Firm | August 11, 2021 |
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| Create Date | September 03, 2021 |
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| Recall Status1 |
Completed |
| Recall Number | Z-2422-2021 |
|---|
| Recall Event ID |
88491 |
| 510(K)Number | K181479 |
|---|
| Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
| Product | Ingenia Ambition X- 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: 781356 |
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| Code Information |
Serial Number Unique Device Identifier (UDI#)
Model: 781356
47077 (01)00884838090040(21)47077
47194 (01)00884838090040(21)47194
47091 (01)00884838090040(21)47091
47040 (01)00884838090040(21)47040
47092 (01)00884838090040(21)47092
47048 (01)00884838090040(21)47048
47195 N/A
47050 (01)00884838090040(21)47050
47209 (01)00884838090040(21)47209
47247 (01)00884838090040(21)47247
47293 (01)00884838090040(21)47293
47001 (01)00884838090040
47032 (01)00884838090040(21)47032
47041 (01)00884838090040(21)47041
47086 (01)00884838090040(21)47086
47248 (01)00884838090040(21)47248
47255 (01)00884838090040(21)47255
47258 (01)00884838090040(21)47258
47275 (01)00884838090040(21)47275
47002 (01)00884838090040(21)47002
47003 (01)00884838090040(21)47003
47000 (01)00884838090040(21)47000
47017 (01)00884838090040(21)47017
47047 (01)00884838090040(21)47047
47056 (01)00884838090040(21)47056
47035 (01)00884838090040(21)47035
47020 (01)00884838090040(21)47020
47078 (01)00884838090040(21)47078
47089 (01)00884838090040(21)47089
47024 (01)00884838090040(21)47024
47097 (01)00884838090040(21)47097
47225 (01)00884838090040(21)47225
47074 (01)00884838090040(21)47074
47058 (01)00884838090040(21)47058
47192 (01)00884838090040(21)47192
47049 (01)00884838090040(21)47049
47019 (01)00884838090040(21)47019
47012 (01)00884838090040(21)47012
47221 (01)00884838090040(21)47221
47276 (01)00884838090040(21)47276
47297 N/A
47270 (01)00884838090040(21)47270
47197 (01)00884838090040(21)47197
47013 (01)00884838090040(21)47013
47015 (01)00884838090040(21)47015
47053 N/A
47014 N/A
47065 N/A
47082 N/A
47099 N/A
47268 N/A
47009 (01)00884838090040(21)47009
47023 (01)00884838090040(21)47023
47030 (01)00884838090040(21)47030
47080 (01)00884838090040(21)47080
47083 (01)00884838090040(21)47083
47245 (01)00884838090040(21)47245
47215 (01)00884838090040(21)47215
47222 (01)00884838090040(21)47222
47299 (01)00884838090040(21)47299
47227 (01)00884838090040(21)47227
47226 (01)00884838090040(21)47226
47265 (01)00884838090040(21)47265
47284 (01)00884838090040(21)47284
47307 (01)00884838090040(21)47307
47057 (01)00884838090040(21)47057
47075 (01)00884838090040(21)47075
47174 (01)00884838090040(21)47174
47088 (01)00884838090040(21)47088
47175 (01)00884838090040(21)47175
47193 (01)00884838090040(21)47193
47081 (01)00884838090040(21)47081
47188 (01)00884838090040(21)47188
47052 (01)00884838090040(21)47052
47059 (01)00884838090040(21)47059
47085 (01)00884838090040(21)47085
47072 (01)00884838090040(21)47072
47184 (01)00884838090040(21)47184
47187 (01)00884838090040(21)47187
47262 (01)00884838090040(21)47262
47211 (01)00884838090040(21)47211
47252 (01)00884838090040(21)47252
47304 (01)00884838090040(21)47304
47298 (01)00884838090040(21)47298
47094 (01)00884838090040(21)47094
47064 (01)00884838090040(21)47064
47244 (01)00884838090040(21)47244
47219 (01)00884838090040(21)47219
47220 (01)00884838090040(21)47220
47096 (01)00884838090040(21)47096
47190 (01)00884838090040(21)47190
47264 (01)00884838090040(21)47264
47034 (01)00884838090040(21)47034
47202 (01)00884838090040(21)47202
47016 (01)00884838090040(21)47016
47269 (01)00884838090040(21)47269
47271 (01)00884838090040(21)47271
47272 N/A
47004 (01)00884838090040(21)47004
47026 (01)00884838090040(21)47026
47006 (01)00884838090040(21)47006
47007 (01)00884838090040(21)47007
47018 (01)00884838090040(21)47018
47027 (01)00884838090040(21)47027
47011 (01)00884838090040(21)47011
47037 (01)00884838090040(21)47037
47039 (01)00884838090040(21)47039
47029 (01)00884838090040(21)47029
47038 (01)00884838090040(21)47038
47043 (01)00884838090040(21)47043
47054 (01)00884838090040(21)47054
47022 (01)00884838090040(21)47022
47044 (01)00884838090040(21)47044
47028 (01)00884838090040(21)47028
47070 (01)00884838090040(21)47070
47062 (01)00884838090040(21)47062
47033 (01)00884838090040(21)47033
47067 (01)00884838090040(21)47067
47045 (01)00884838090040(21)47045
47060 (01)00884838090040(21)47060
47025 (01)00884838090040(21)47025
47051 (01)00884838090040(21)47051
47063 (01)00884838090040(21)47063
47061 (01)00884838090040(21)47061
47071 (01)00884838090040(21)47071
47066 (01)00884838090040(21)47066
47084 (01)00884838090040(21)47084
47098 (01)00884838090040(21)47098
47095 (01)00884838090040(21)47095
47198 (01)00884838090040(21)47198
47093 (01)00884838090040(21)47093
47177 (01)00884838090040(21)47177
47196 (01)00884838090040(21)47196
47199 (01)00884838090040(21)47199
47203 (01)00884838090040(21)47203
47206 (01)00884838090040(21)47206
47068 (01)00884838090040(21)47068
47183 (01)00884838090040(21)47183
47279 (01)00884838090040(21)47279
47208 (01)00884838090040(21)47208
47260 (01)00884838090040(21)47260
47282 (01)00884838090040(21)47282
47216 (01)00884838090040(21)47216
47185 (01)00884838090040(21)47185
47233 (01)00884838090040(21)47233
47292 (01)00884838090040(21)47292
|
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 | 147 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.
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = LNH
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