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Class 2 Device Recall Philips |
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| Date Initiated by Firm |
August 11, 2021 |
| Create Date |
September 03, 2021 |
| Recall Status1 |
Completed |
| Recall Number |
Z-2413-2021 |
| Recall Event ID |
88491 |
| 510(K)Number |
K153324
|
| Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
| Product |
Ingenia 1.5T S-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
Model: 781347
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| Code Information |
Model: 78137
Serial Number Unique Device Identifier (UDI#)
81045 N/A
81075 (01)00884838068421(21)81075
81076 (01)00884838068421(21)81076
81077 (01)00884838068421(21)81077
81096 (01)00884838068421(21)81096
81124 (01)00884838068421(21)81124
81114 (01)00884838068421(21)81114
81126 (01)00884838068421(21)81126
81125 (01)00884838068421(21)81125
81144 (01)00884838068421(21)81144
81145 (01)00884838068421(21)81145
81159 (01)00884838068421(21)81159
81003 N/A
81111 (01)00884838068421(21)81111
81050 N/A
81051 (01)00884838068421(21)81051
81090 (01)00884838068421(21)81090
81021 N/A
81038 N/A
81185 (01)00884838068421(21)81185
81179 (01)00884838068421(21)81179
81005 N/A
81006 N/A
81011 N/A
81009 N/A
81019 N/A
81020 N/A
81016 N/A
81023 N/A
81017 N/A
81024 N/A
81014 N/A
81018 N/A
81004 N/A
81041 N/A
81057 (01)00884838068421(21)81057
81055 (01)00884838068421(21)81055
81037 (01)00884838068421(21)81037
81049 (01)00884838068421(21)81049
81060 (01)00884838068421(21)81060
81056 (01)00884838068421(21)81056
81064 (01)00884838068421(21)81064
81062 (01)00884838068421(21)81062
81070 (01)00884838068421(21)81070
81078 (01)00884838068421(21)81078
81073 (01)00884838068421(21)81073
81074 (01)00884838068421(21)81074
81112 (01)00884838068421(21)81112
81115 (01)00884838068421(21)81115
81122 (01)00884838068421(21)81122
81147 (01)00884838068421(21)81147
81146 (01)00884838068421(21)81146
81153 (01)00884838068421(21)81153
81156 (01)00884838068421(21)81156
81158 (01)00884838068421(21)81158
81093 (01)00884838068421(21)81093
81027 N/A
81035 N/A
81010 (01)00884838068421(21)81010
81063 (01)00884838068421(21)81063
81028 (01)00884838068421(21)81028
81030 (01)00884838068421(21)81030
81106 (01)00884838068421(21)81106
81052 N/A
81067 (01)00884838068421(21)81067
81105 (01)00884838068421(21)81105
81116 (01)00884838068421(21)81116
81013 N/A
81007 N/A
81008 N/A
81040 N/A
81031 (01)00884838068421(21)81031
81152 (01)00884838068421(21)81152
81044 N/A
81167 (01)00884838068421(21)81167
81170 (01)00884838068421(21)81170
81171 (01)00884838068421(21)81171
81047 (01)00884838068421(21)81047
81059 (01)00884838068421(21)81059
81108 (01)00884838068421(21)81108
81148 (01)00884838068421(21)81148
81133 (01)00884838068421(21)81133
81001 N/A
81086 (01)00884838068421(21)81086
81118 (01)00884838068421(21)81118
81139 (01)00884838068421(21)81139
81140 (01)00884838068421(21)81140
81138 (01)00884838068421(21)81138
81151 (01)00884838068421(21)81151
81175 N/A
81184 N/A
81079 (01)00884838068421(21)81079
81069 (01)00884838068421(21)81069
81061 (01)00884838068421(21)81061
81065 (01)00884838068421(21)81065
81098 (01)00884838068421(21)81098
81085 (01)00884838068421(21)81085
81092 (01)00884838068421(21)81092
81091 (01)00884838068421(21)81091
81032 N/A
81043 (01)00884838068421(21)81043
81026 N/A
81129 (01)00884838068421(21)81129
81131 (01)00884838068421(21)81131
81149 (01)00884838068421(21)81149
81155 (01)00884838068421(21)81155
81162 (01)00884838068421(21)81162
81172 (01)00884838068421(21)81172
81165 (01)00884838068421(21)81165
81180 (01)00884838068421(21)81180
81084 (01)00884838068421(21)81084
81087 (01)00884838068421(21)81087
81088 (01)00884838068421(21)81088
81095 (01)00884838068421(21)81095
81094 (01)00884838068421(21)81094
81100 (01)00884838068421(21)81100
81127 (01)00884838068421(21)81127
81132 (01)00884838068421(21)81132
81174 (01)00884838068421(21)81174
81039 N/A
81071 (01)00884838068421(21)81071
81157 (01)00884838068421(21)81157
81176 (01)00884838068421(21)81176
81117 (01)00884838068421(21)81117
81173 (01)00884838068421(21)81173
81025 N/A
81097 (01)00884838068421(21)81097
81154 (01)00884838068421(21)81154
81015 N/A
81029 N/A
81046 N/A
81033 N/A
81034 N/A
81048 N/A
81042 N/A
81058 (01)00884838068421(21)81058
81080 (01)00884838068421(21)81080
81072 (01)00884838068421(21)81072
81103 (01)00884838068421(21)81103
81113 (01)00884838068421(21)81113
81123 (01)00884838068421(21)81123
81128 (01)00884838068421(21)81128
81137 (01)00884838068421(21)81137
81178 (01)00884838068421(21)81178
|
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 |
144 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 and Original Applicant = PHILIPS MEDICAL SYSTEMS, NEDERLANDS B.V.
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